Tissue ligation devices and tensioning devices therefor

ABSTRACT

Described here are closure devices and methods for ligating tissue, such as the left atrial appendage, and tensioning devices and mechanism for actuating these devices. The tensioning mechanisms and devices may allow a user to apply one or more predetermined forces to a suture or other portion of the closure devices. The closure devices may comprise a suture loop releasably attached to a snare loop assembly, and a tensioning mechanism or device may be configured to tighten the suture loop and/or release the suture loop from the snare loop assembly.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application Ser.No. 61/494,845, filed on Jun. 8, 2011, which is hereby incorporated byreference in its entirety.

FIELD

This invention relates generally to devices and methods for ligatingtissue, such as the left atrial appendage, using surgically, minimallyinvasive or intravascular approaches, and to tensioning devices foractuating these devices.

BACKGROUND

Atrial fibrillation is a common problem that afflicts millions ofpatients. Atrial fibrillation often results in the formation of athrombus, or clot, in the appendage of the left atrium. This presents aproblem, inasmuch as the thrombus can dislodge and embolize to distantorgans, which may result in adverse events such as a stroke. For thisreason, most patients with atrial fibrillation are treated with one ormore blood thinners to help prevent the formation of a thrombus. Bloodthinners, however, can present health risks of their own, especially inthe elderly. These risks, such as bleeding, often require a user to makesignificant lifestyle changes.

Several methods have been developed to address the potential problem ofthrombus formation in the left atrial appendage. One such methodincludes suturing the left atrial appendage along the base or ostialneck where it joins the atrial chamber. In this way, blood flow into theatrial appendage is cut off, eliminating the risk of thrombus formationtherein. This is typically done through open-heart surgery, which limitsthe availability of the procedure to those who are at a particularlyhigh risk, or who are otherwise undergoing an open-heart procedure. Inaddition, open-heart surgery requires general anesthesia and has anumber of well-known risks, making it less desirable.

Other methods have also been investigated. These methods include methodsof stapling the base of the appendage and methods of filling theappendage with a space occupying or occluding member. Stapling is notpreferred given the fragility of the appendage and its tendency torupture, while occlusion devices may not effectively prevent all bloodflow into the appendage.

Additional devices and methods for closing the left atrial appendage orother suitable tissues would therefore be desirable. In particular,devices and methods for closing the left atrial appendage usingminimally invasive, intravascular, or a combination of these techniques,would be desirable in order to avoid the need for opening the chest. Ofcourse, additional devices for use in open surgical procedures aredesirable as well, especially when those devices offer additionaladvantages over standard devices.

BRIEF SUMMARY

Described here are closure devices for closing one or more tissues, andmechanisms for controlling these devices. Generally, the closure devicesdescribed here comprise a snare loop assembly, wherein the snare loopassembly comprises a snare and a suture loop, an elongate body, and amechanism for controlling the snare loop assembly which may be mountedon a handle. In some variations the snare loop assembly may comprise aretention member that may releasably couple the suture loop and thesnare. In other variations the devices comprise one or moreforce-reducing suture locks to help prevent the suture loop frominadvertently disengaging from the snare loop assembly. Additionally,the closure devices may comprise one or more tensioning devices fortensioning or otherwise tightening the suture loop.

In some variations, the tensioning device may comprise a force gauge. Insome variations, the tensioning device may further comprise a handleportion, a suture attachment mechanism, and a force indicator. Sutureattachment mechanism may be one or more structures capable of coupling,permanently or reversibly, to a portion of a suture loop (e.g., a tailof the suture). In some variations, the suture attachment mechanism maybe configured to attach to a suture fob that is in engagement with aportion of the suture loop. In some variations, the suture attachmentmechanism may be attached to the force gauge, such that tension appliedto the suture by the tensioning device may be measured by the forcegauge. In variations that include a force indicator, the force indicatormay give an indication of the tension measured by the force gauge. Insome variations, the force indicator may comprise a digital display,which may display the force measured by the force gauge. In othervariations, the force indicator may comprise one or more lights, whichmay turn on (or off) when the tension measured by the force gaugereaches one or more predetermined tension levels. In other variations,the force indicator may comprise a moveable marker which may move alonga scale as a function of the tension measured by the force gauge. Insome variations, the scale may comprise one or more marks which mayrepresent one or more predetermined tension values.

In other variations, the tensioning device may comprise one or moreclutches. In some variations, the tensioning device may comprises abase, a rotation knob, a spooling member, a first clutch, and a secondclutch. In some variations, the base of the tensioning member may beattached to a handle of a closure member. In some variations, the firstand second clutch may frictionally engage the spooling member. In somevariations, rotation of the rotation knob may rotate the first clutch,and the frictional engagement between the first clutch and the spoolingmember may cause the spooling member to rotate relative to the base. Insome of these variations, the suture may be attached to the spoolingmember, such that rotation of the spooling member causes the suture towrap around the spooling member. In some variations, the rotation knobcomprises a switch and an engagement rod, and wherein the switch ismoveable between a first position in which the engagement rod may rotaterelative to the second clutch, and a second position in which theengagement rod engages a second clutch and is rotatably connected to thesecond clutch. In some of these variations, when the switch is in thefirst position, rotation of rotation knob may cause spooling member torotate around the base until the tension in the suture reaches a firstpredetermined force. Once the tension reaches the first predeterminedforce, the first clutch may begin to slip relative to the spoolingmember such that the spooling member is no longer rotated. In somevariations, the switch may be placed in the second position to engagethe second clutch, and rotation of rotation knob may cause spoolingmember to rotate around the base until the tension in the suture reachesa second predetermined force. Once the tension reaches the secondpredetermined force, the first and second clutches may begin to sliprelative to the spooling member such that the spooling member is nolonger rotated.

In other variations the tensioning device may comprise one or moreconstant force springs. In some of these variations, the tensioningdevice may comprise a housing; a first extension member slidablerelative to housing; a first constant force spring attached to thehousing and the first extension member and a suture attachment mechanismfor coupling the tensioning device to a portion of a suture loop. Insome of these variations, the tensioning device may comprise a secondextension member and a second constant force spring, wherein the secondconstant force spring may be attached to the housing and the secondextension member. In some of these variations, the first extensionmember may be releasably couplable to the second extension member.

In other variations, a closure device may comprise a tensioningmechanism comprising a rotation knob, an indicator body, and a springmember rotatably connecting the rotation knob and the indicator body. Insome of these variations, rotation of the rotation knob may tighten asuture loop, the relative rotational positioning between the rotationknob and the indicator body may indicate an amount of force applied to aportion of the suture loop (e.g., a tail of the loop). In somevariations, the tensioning mechanism may further comprise an axle,wherein the indicator body and axle are fixedly connected and whereinthe indicator body and axle are rotatably coupled to a handle of theclosure device. In some of these variations, the tensioning mechanismmay further comprise a spool, wherein rotation of the axle rotates thespool. In these variations, rotation of the spool may tighten the sutureloop. In some variations, the indicator body may comprise at least onemarking, the rotation knob may comprise at least one marking, and therelative positioning between the at least one marking of the indicatorbody and the at least one marking of the rotation knob may indicate anamount of force applied to the suture loop.

Also described here are methods for closing one or more tissues. Forexample, in some variations, a method may comprise introducing a closuredevice into a body, wherein the closure device comprises a snare loopassembly having an opened configuration and a closed configuration andcomprising a suture loop releasably coupled to the snare loop assembly,advancing the snare loop assembly to ensnare the target tissue, closingthe snare loop assembly around the target tissue; applying a firstpredetermined tension to the suture loop to release the suture loop fromthe snare loop assembly, and applying a second predetermined tension tothe suture loop to tighten the suture loop around the target tissue. Insome variations, the target tissue may comprise the left atrialappendage. In some variations, the methods may comprise opening thesnare loop assembly to the open configuration after releasing the sutureloop from the snare loop assembly. Additionally or alternatively, themethod may further comprise re-tightening the suture loop after a firsttime period following applying the second predetermined tension to thesuture loop. In some of these variations, the first time period may beat least thirty seconds. In other variations, the first time period maybe at least two minutes. Additionally or alternatively, in somevariations re-tightening the suture loop may comprise applying a thirdpredetermined tension to the suture loop. The third predeterminedtension may be greater than or less than the second predeterminedtension. In other methods, re-tightening the suture loop may compriseapplying the second predetermined tension to the suture loop. In somevariations, applying the first predetermined tension to the suture loopmay comprise applying the first predetermined tension to the suture loopusing a first tensioning device. In some of these variations, applyingthe second predetermined tension to the suture loop may compriseapplying the second predetermined tension to the suture loop using thefirst tensioning device. In others of these variations, applying thesecond predetermined tension to the suture loop may comprise applyingthe second predetermined tension to the suture loop using a secondtensioning device. Any suitable tensioning device (or combination oftensioning device), such as those described hereinthroughout, may beused with the methods described here.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a view of a distal end of an illustrative device having asnare loop assembly.

FIG. 2 is a view of a distal end of a snare loop assembly, including asuture hook.

FIG. 3A is a perspective view of one variation of a handle suitable foruse with the devices described here. FIG. 3B is a cross-sectional bottomview of the handle shown in FIG. 3A.

FIGS. 4-9 are perspective views of variations of handles suitable foruse with the devices described here.

FIGS. 10 and 11 are cross-sectional side views of portions of twovariations of the closure devices described here.

FIGS. 12 and 13A-13C illustrate two variations of snare loop assembliessuitable for use with the closure devices described here.

FIG. 14 shows a perspective view of an illustrative variation of theclosure devices described here.

FIG. 15 shows a cross-sectional side view of a portion of one variationof the closure devices described here comprising a pulley suture.

FIGS. 16A-16B illustrate a variation of the closure devices describedhere in which a snare is releasably connected to an elongate body.

FIGS. 17A-17D illustrate different illustrative variations of snareconfigurations.

FIGS. 18A and 18B depict a perspective view and a side view,respectively, of a variation of a snare. FIGS. 18C and 18D depict amethod by which the snare of FIGS. 18A and 18B may be used to ensnaretissue.

FIGS. 19A-19G illustrate several variations of knot shielding mechanismssuitable for use with the closure devices described here.

FIGS. 20A-20C depict illustrative retention members that may be usedwith the devices described here.

FIG. 21 depicts an illustrative variation of an elongate body suitablefor use with the devices described here.

FIGS. 22A and 22B depict a perspective view and a top view,respectively, of one variation of separation tubing suitable for usewith the devices described here. FIGS. 22C and 22D depict a perspectiveview and a top view, respectively, of another variation of separationtubing suitable for use with the devices described here.

FIG. 23A depicts a front view of one illustrative variation of a tipportion suitable for use with the devices described here. FIGS. 23B and23C depict cross-sectional side views of the tip portion of FIG. 23A.

FIGS. 24A and 24B depict portions of two variations of tip portionssuitable for use with the devices described here.

FIGS. 25A-25C depicts a perspective view, a front view, and across-sectional side view, respectively of an illustrative variation ofa tip portion suitable for use with the devices described here. FIG. 25Dillustrates a cross-sectional side view of one variation of a closuredevice incorporating the tip portion illustrated in FIGS. 25A-25C.

FIGS. 26A and 26B show an illustrative variation of a closure devicecomprising separation tubing.

FIG. 27 depicts an illustrative variation of a closure device comprisingseparation tubing and a suture tube.

FIGS. 28A and 28B depict a variation of a suture tube suitable for usewith the devices described here.

FIG. 29 depicts a cross-sectional side view of a suture tube suitablefor use with the devices described here.

FIGS. 30A-30D depict a variation of the closure devices described herecomprising a pulley suture.

FIGS. 31A and 31B depict two variations of tensioning devices suitablefor use with the closure devices described here.

FIG. 32A depicts a perspective view of a variation of a tensioningdevice suitable for use with the closure devices described here. FIGS.32B and 32C depict partial cross-sectional views of the tensioningdevice shown in FIG. 32A.

FIGS. 33A-33G depict a variation of a tensioning device suitable for usewith the closure devices described here.

FIG. 34 depicts a method of using a closure device having a suture loopto close a tissue.

FIGS. 35A-35D depict a variation of a closure device comprising atensioning mechanism.

DETAILED DESCRIPTION

Described here are closure devices, handles and tensioning devices foractuating closure devices, and methods for closing tissues using one ormore closure devices. Generally, the closure devices comprise a snareloop assembly comprising a snare and a suture loop, such as thosedescribed in U.S. patent application Ser. No. 12/055,213, entitled“Devices, Systems, and Methods for Closing the Left Atrial Appendage”and filed on Mar. 5, 2008, and U.S. patent application Ser. No.12/752,873, entitled “Tissue Ligation Devices and Controls Therefor” andfiled on Apr. 1, 2010, each of which is incorporated by reference hereinin their entirety. The devices described here may be suitable for usewith minimally invasive access to the left atrial appendage (e.g.,through a small incision above, beneath or through the rib cage, throughan incision in the costal cartilage or the xiphoid, through a port,through the vasculature, etc.).

Generally, the closure devices described here comprise an elongate body,and a snare loop assembly. In some variations the closure devices mayfurther comprise a handle and/or a tensioning device. A handle or othercontrol mechanism (e.g., a surgical master-slave robotic system) may beused to control and actuate the snare loop assembly through the elongatebody, as will be explained in more detail below. The snare loopassembly, in turn, may be used to temporarily or permanently close,tighten, ligate or other restrict tissue. To achieve this, the snareloop assembly may be changed between a delivery, or “closed,”configuration and a deployed, or “open,” configuration, and vice versa,as will be described in more detail below. Placing the snare loopassembly in a closed configuration may allow for low-profile advancementof the snare loop assembly to a target location, or may allow the snareloop assembly to close around a target tissue. Conversely, placing asnare loop assembly in an open configuration may allow the snare loopassembly to be placed around one or more target tissues, or may allowthe snare loop assembly to release one or more target tissues previouslyclosed by the snare loop assembly.

In use, a distal end of an elongate body may be advanced into the bodytoward a target tissue (e.g., the left atrial appendage). Thisadvancement may be done in a minimally invasive manner. Duringadvancement, the snare loop assembly may be in a closed configuration tohelp prevent the snare loop assembly from snagging or catching on tissueor other obstructions. Once the distal end of the elongate body hasreached a location at or near the target tissue, the snare loop assemblymay be opened to a deployed configuration. The snare loop assembly maythen be advanced, moved, or otherwise manipulated to encircle at least aportion of the target tissue. The snare loop assembly may then be closedaround the encircled tissue to close, ligate, or otherwise restrict thetarget tissue. The snare loop assembly may be re-opened, repositioned,and re-closed as necessary. In some instances, a suture loop (not shown)or other restricting device may be tightened and released from theclosure device to maintain the target tissue in a closed fashion. Toremove the closure device from the body, the snare loop assembly mayagain be opened to release the target tissue (it should be appreciatedthat the suture loop or other closure device may remain in place) suchthat the snare loop assembly and elongate body may be withdrawn. Oncethe target tissue is released, the snare loop assembly may be closed tofacilitate low-profile withdrawal. In variations where the closuredevice comprises a tensioning device or mechanism, the tensioning deviceor mechanism may be used to release the suture loop from the snare loopassembly and/or tighten the suture loop, as will be described in moredetail below.

The closure devices may contain one or more additional features, as willbe described in more detail below. In some variations, the snare loopassembly comprises one or more force-reducing suture locks. Theseelements, as will be described in more detail below, may act toreleasably or permanently connect various components of the snare loopassembly while reducing forces that are transmitted to one or moreportions of the snare loop assembly. In other variations, the closuredevice may comprise one or more features that helps maintain at least aportion of the suture loop inside of the elongate body when the deviceis in an opened and/or closed configuration. In some of thesevariations, the closure device may comprise a suture hook that engages aportion of the snare loop assembly. In other variations, the elongatebody may comprise one or more pieces of separation tubing. Thisseparation tubing may further comprise a suture tube attached theretofor releasably holding at least a portion of the suture loop. In stillother variations, the elongate body may comprise a pulley suture thatengages one or more portions of the snare loop assembly. Each of thesefeatures will be described in more detail below, and it should beappreciated that the closure devices described here may comprise anycombination of these features.

FIG. 14 depicts one illustrative variation of closure device (1400).Shown there is snare loop assembly (1402), elongate body (1404), andhandle (1406). As noted above, handle (1406) may be used to control andactuate the snare loop assembly (1402) through the elongate body (1404)in order to move snare loop assembly (1402) between a closedconfiguration (as shown in FIG. 14) and a deployed configuration (notshown), and vice versa.

Snare Loop Assembly

As mentioned above, the snare loop assemblies of the closure devicesdescribed here may be used to temporarily close or restrict one or moretarget tissues. Generally the snare loop assembly comprises a snare, asuture loop, and a retention member at least temporarily connecting thesnare and the suture loop. The snare loop assembly may also comprise oneor more force-reducing suture locks, as will be described in more detailbelow. FIG. 1 shows an illustrative variation of snare loop assembly(100) comprising snare (102), suture loop (104), and retention member(106). Snare loop assembly (100) may be at least partially disposed inelongate body (108) having tip (110). Snare loop assembly (100) is shownin FIG. 1 in an open configuration, and the portion of snare loopassembly (100) extending out of elongate body (104) may define acontinuous aperture therethrough. This aperture may be defined by one ormore components of the snare loop assembly (100) (e.g., the snare), andmay be suitable for encircling tissue such as the left atrial appendage.Generally, the snare (102) may be used to open and close the snare loopassembly (100), as will be described in more detail below. In someinstances, retention member (106) may be configured to releasably couplesuture loop (104) and snare (102), and may be configured to releasesuture loop (104) from snare loop assembly (100) upon application ofsufficient force to suture loop (104).

Snare

In variations of snare loop assemblies comprising a snare, the snare maybe at least partially moveable to change a snare loop assembly betweenopen and closed configurations. Generally, a portion of the snare may behoused in the elongate body, and another portion of the snare may extendoutside of the distal end of the elongate body to at least partiallydefine the aperture of the snare loop assembly. In some variations, oneend of the snare is fixed relative to one or more portions of theclosure device, while the other end may be advanced or retracted throughthe elongate body. Movement of the free end of snare may change theamount of the snare loop assembly that is disposed outside of elongatebody, and thus change the size of the aperture defined thereby.Specifically, advancement of the snare through the elongate body mayincrease the size of the snare loop assembly aperture, while retractionof the snare may decrease the size of the snare loop assembly apertureto close the snare loop assembly. The free end of the snare may bemanipulated in any suitable manner. In some variations, the snare may beattached directly to one or more portions of the handle, as will bedescribed in more detail below. In other variations, a hypotube, rod, orother rigid structure may be attached to the free end of the snare. Thisstructure may in turn be moved by the handle, which may help facilitateadvancement or withdrawal of the snare through the elongate body.

In variations where one end of the snare is fixed relative to theclosure device, the snare may be fixed to any suitable portion of thedevice. For example, in some variations one end of the snare may befixedly held in, on, or near a tip of the elongate body. In othervariations, the fixed end of the snare may be affixed in one or morelumens of the elongate body. In still other variations, the fixed end ofsnare may be at least temporarily attached to the device's handle.Although one end of the snare may be temporarily fixed relative to theclosure device, it should be appreciated that this fixed end may beconfigured to be releasable and/or moveable. Configuring the fixed endof the snare to be releasable and/or movable may serve a number ofuseful functions. In some instances, temporary or permanent devicefailure may result in the moveable portion of the snare becoming stuckor caught. In these instances, it may be necessary to release the fixedend in order to allow the closure device to release ensnared tissue. Inother instances, it may be desirable to move the free end in order toprovide for adjustment of the snare using both ends.

When one end of the snare is configured to be temporarily fixed relativeto the elongate body, the end of snare may be released from its fixedrelation in any suitable manner. For example, in some variations, an endof the snare may be temporarily held in a fixed manner by a frangiblemember. FIGS. 16A and 16B illustrate one variation by which an end of asnare (1600) may be releasably fixed to an elongate body (1602) by afrangible member (1604). Specifically, FIGS. 16A and 16B show a portionof elongate body (1602) having at least one lumen (1605). In thisvariation, a portion of lumen (1605) may be subdivided into at leastfirst and second sub-lumens ((1606) and (1608) respectively). As shownin FIG. 16A, first sub-lumen (1606) has a first section (1610) with afirst cross-sectional area, and a second section (1612) with a secondcross-sectional area. The end of snare (1600) may be placed in firstsection (1610) of first sub-lumen (1606), and may be attached to thedistal end of frangible member (1604), as shown in FIG. 16A. Frangiblemember (1604) may pass through second section (1612) of first sub-lumen(1606) and through lumen (1605).

The attachment of snare (1600) to frangible member (1604) may helptemporarily lock the end of snare (1600) in place. The proximal end (notshown) of frangible member (1604) may be temporarily attached in a fixedmanner to one or more portions of the device handle (not shown). Becausethe proximal end of the frangible member (1604) is held in place, thefrangible member (1604) may prevent the snare from being pulled distallyout of the end of the elongate body (1602). Additionally, thecross-sectional area of first section (1610) may be different from thecross-sectional area of the second section (1612) such that the end ofsnare (1600) is unable to pass from first section (1610) into secondsection (1612). In this way, the snare (1600) is prevented from movingproximally into the elongate body (1602). Additionally, in somevariations, at least a portion of snare (1600) and first section (1610)may have non-circular cross sections (e.g., oval, triangle, square,polygon, or shape with irregular geometry) such that the snare (1600)housed within first section (1610) may be unable to rotate relative tofirst section (1610). Because the end of snare (1600) is prevented frommoving proximally, distally, or rotating relative to first section(1610) of first sub-lumen (1606), the end of snare may be effectivelyimmobilized relative to the elongate body (1602).

Frangible member (1604) may be configured such that application of asufficient force to frangible member (1604) is sufficient to break theattachment between frangible member (1604) and snare (1600). To releasesnare (1600) from its fixed position, a user may pull on the proximalend of frangible member (1604) directly or indirectly (e.g., via one ormore handle components). Because the snare (1600) is prevented frommoving proximally into second section (1612), sufficient proximal forceapplied to the frangible member (1604) may act to break the engagementbetween frangible member (1604) and snare (1600), thereby releasing thesnare (1600) as shown in FIG. 16B.

The snares described here may be made of any suitable material orcombination of materials. For example, in some variations the snare maybe made from a shape-memory material, such as a shape-memory alloy(e.g., a nickel titanium alloy, etc.), or may be made from stainlesssteel, polyester, nylon, polyethylene, polypropylene, combinationsthereof, and the like. In variations where the snare is made from theshape-memory material, the snare may be configured to take on aparticular shape or configuration when the snare loop assembly is placedin an open configuration, but may still be at least partially withdrawninto the elongate body to place the snare loop assembly in a closedconfiguration. For example, as shown in FIG. 1 above, snare (102) mayform a generally circular loop when snare loop assembly (100) is placedin an open configuration. While shown in FIG. 1 as being generallycircular, snare (102) may form a loop of any given shape. FIGS. 17A-17Dillustrate several additional snare configurations. In the variationshown in FIG. 17A, snare (1700) may form a teardrop-shaped loop (1702)when in a deployed configuration. In the variation shown in FIG. 17B,snare (1704) may form an oval or ellipsoid loop (1706) when in adeployed configuration. In the variation shown in FIG. 17C, snare (1708)may take on a substantially triangular loop (1709) when in a deployedconfiguration. Furthermore, in some variation, the snare loop may beangled relative to the elongate body. For example, FIG. 17D shows a sideview of closure device (1710), in which snare (1712) exits elongate body(1714) that is at an angle (θ) relative to the elongate body'slongitudinal axis (1716). This angle (θ) may be any suitable angle. Forexample, angle (θ) may be about 5°, about 15°, about 30°, about 45°,about 60°, about 75°, about 90°, between about 40° and about 50°,between about 35° and about 55°, between about 30° and about 60°, or thelike. Angling snare (1712) relative to elongate body (1714) may aid thesnare (1712) in capturing tissue, as angling may better position thesnare (1712) relative to tissue as the closure device is moved in thebody.

FIGS. 18A-18D illustrate yet another variation of snare (1800). In thisvariation, snare (1800) may form a hook-shaped loop (1802) when snare(1800) extends from elongate body (1804) in an open configuration. FIG.18A shows a perspective view of snare (1800), while 18B shows a sideview of snare (1800). Because the loop (1802) bends back over itself toform a hook shape (as highlighted in a side view in FIG. 18B), the snare(1800) may help create space between body tissues when in an openconfiguration. For example, when opened in the pericardial space, asshown in FIG. 18C, the snare (1800) may lift the pericardial sac (1806)away from the heart (1808). Creating additional space within thepericardial sac may make it easier for snare (1800) to capture tissue,such as the left atrial appendage (1810), as shown in FIG. 18D.

Suture Loop

The snare loop assemblies described here may also comprise a suture loopfor maintaining tissue in a closed manner. Generally, the suture loopmay be releasably attached to the snare, for example, via a retentionmember, as will be described in more detail below. Furthermore, thesuture loop may comprise a suture knot, but need not. This suture knotmay be any suitable knot, including, but not limited to, a slip knot(e.g., a one-way slip knot). In some variations, as will be described inmore detail below, at least a portion of the knot may be held within thetip of elongate body. In other variations, the suture knot may betemporarily held in fixed relation to the elongate body, as will bedescribed in more detail below.

In variations where the suture loop comprises a slip knot, suture may beadvanced or withdrawn through the slip knot to change the size of sutureloop. In some instances where the suture knot is held within or againsta tip of elongate body, the suture knot may not move while the size ofsuture loop is changed. This may help prevent the closure device fromdamaging tissue, as will be described in more detail below.

In some variations, the suture loop further comprises a unidirectionallocking structure. In these variations, the unidirectional lockingstructure may be any structure capable of being advanced along thesuture in one direction, but resisting movement in a second direction.In these variations, the locking structure may be advanced over aportion of the suture loop to help lock a suture knot in place. Forexample, in some variations the unidirectional locking structure maycomprise a bead or mechanical structure which is placed at leastpartially around the suture. In these variations, the bead may compriseone or more teeth or projections that allow for the bead to be advancedalong the suture in one direction, but prevents or resists movement inthe opposite direction. The locking structure may be advanced via one ofthe closure devices described here, or may be advanced by a separatedevice after the suture loop has been released from the closure device.

Suture loop may be made from any suitable material useful in exclusionor closure. For example, it may be made of a biodegradable material(e.g., polylactic acid, polyglycolic acid, polylactic-co-glycolic acid,etc.), or may be made of a non-biodegradable material (e.g., metal,steel, polyester, nylon, propylene, silk, combinations thereof and thelike).

When the suture loop is tightened to close tissue, it may be possiblefor tissue to be pulled into the suture knot of the suture loop. If toomuch tissue is pulled into the suture knot, the suture knot may clog orjam in a way that prevents the suture loop from being further tightened.In some variations the suture loop may comprise one or more pledgets ortube sections to help shield a portion of the suture knot. FIGS. 19A-19Gillustrate several variations of suture loops comprising knot-shieldingelements. In FIG. 19A, two legs of suture loop (1900) are threadedthrough a pledget (1902). The pledget or pledgets used with the devicesdescribed herein may be made from any suitable material, such as, forexample, polyurethane foam, felt, Teflon fabric, Dacron, collagen, orthe like. FIG. 19B shows another variation of suture loop (1904) inwhich pledget (1905) is doubled over and two legs of suture loop (1904)are threaded therethrough. By increasing the thickness of pledget (1905)disposed between suture knot (1906) and tissue (not shown), the pledget(1905) may further reduce the amount of tissue that is pulled intosuture knot (1906). FIG. 19C shows yet another variation of suture loop(1908) comprising pledget (1910), in which only a portion of pledget(1910) is doubled over. In this variation, one leg (1912) of suture loop(1908) may be threaded through the doubled-back portion of pledget(1910) while the other leg is threaded through the single-layeredportion of pledget (1910).

FIG. 19D shows still another variation of suture loop (1914), in whichone leg (1916) of suture loop (1914) and free end (1918) of suture loop(1914) are threaded through pledget (1920). FIG. 19E shows a variationof suture loop (1922) in which both legs and a free end (1924) of sutureloop (1922) are all threaded through a pledget (1926). It should beappreciated that in some of these variations, one or more portions ofpledget (1926) may be sized or otherwise configured to fit in one ormore portions, lumens or recesses of the elongate body. FIG. 19F shows avariation of suture loop (1928) in which suture knot (1930) is at leastpartially shielded by tubing (1932). In this variation, the legs ofsuture loop (1928) may pass through the ends of tubing (1932), whilesuture knot (1930) may exit out of an aperture (1934) in the side of thetubing (1932). FIG. 19G shows another variation of suture loop (1936) inwhich the suture knot (not shown) is shielded by tubing (1938). In thisvariation, legs of suture loop (1936) may exit out of slots (1940) inthe sides of tubing (1938), while the free end of suture loop (1936) mayexit out of one end of the tubing (1938).

Retention Member

FIGS. 20A-20C depict illustrative retention members that may be usedwith the devices described herein. FIG. 20A shows an end view of aretention member (2014) having first and second lumens (2016, 2018) forretaining a closure element and a suture loop therein. In thisvariation, the second lumen (2018) has a slit or other opening (2020)along its length, for allowing the suture to pass therethrough when itis ready to be deployed. Of course, it should be understood that thefirst and second lumens may be positioned or oriented in any suitableway with respect to each other, and similarly, the slit or other openingon the second lumen may be positioned or oriented in any suitablefashion with respect to the first lumen (e.g., it may be approximately180°, approximately 150°, approximately 120°, approximately 90°,approximately 60°, approximately 30°, or the like, from the first lumen(2016)). FIG. 20B provides an illustration of a retention member havinga first lumen (2022), a second lumen (2024), and a slit (2026). In thisvariation, the slit (2026) is positioned closer to the first lumen(2022) than the slit of FIG. 20A. The width or spacing of the slitopening may be selected as desired or appropriate. Similarly, the slitneed not extend or be continuous along the entire length of theretention member. In some variations, the slits may have prongs or armsalong its length to help capture and retain the suture therein. In othervariations, the slits may be covered at spaced apart locationstherealong with a biodegradable polymer, temporarily used to tack orhold down the suture. Of course, in still other variations, theretention member does not comprise a slit, and instead comprises someother type of retention mechanism, such as the prongs or tacks describedjust above. In yet other variations, there are no slits or openings inthe retention member and the suture loop is released upon removing orwithdrawing the retention member and closing the device.

FIG. 20C provides another variation of a retention member. In thisvariation, the retention member has a first lumen (2028), second lumen(2030), and a separation region (2032). The separation region may beconstructed in any suitable fashion. For example, the separation regionmay comprise a perforated region adapted to perforate and release thesuture with the application of force. Alternatively, the separationregion may be a thin-walled or other type of weakened region that may beconfigured to break and release the suture. It should be understood thatthe retention member may have any suitable geometry or shape, and may bemade from any suitable material. Similarly, the lumens need not be fullcircles or have a circular cross-sectional geometry. When these or othertypes of retention members are used, the suture loop may be torn out,pulled through, or otherwise released from the retention member after ithas been properly positioned and tightened as desirable.

Elongate Body

As mentioned briefly above, the elongate body of the closure devicesdescribed here may connect the distal end of the snare loop assembly andthe handle or actuating mechanism while still allowing for control ofthe snare loop assembly through the elongate body. Specifically, atleast a portion of some of the snare loop assembly components may behoused within elongate body, and may be connected to the handle throughthe elongate body. In some variations, at least a portion of theelongate body may be flexible, which may help facilitate navigation ofthe elongate body in and through tissue.

FIG. 21 shows one illustrative variation of an elongate body suitablefor use with the closure devices described here. Shown there is elongatebody (2100) attached to handle portion (2102). Elongate body (2100) maycomprise tip portion (2103), curve (2104), first lumen (2106), secondlumen (2108), and third lumen (2110). While shown in FIG. 21 as having asingle curve (2104), elongate body (2100) may have no curves or may havemultiple curves in different portions of the elongate body (2100).Furthermore, in some variations the closure device may comprise one ormore mechanisms that may act or function to change the shape of theelongate body (2100). In instances where the elongate body (2100)comprises one or more curves (2104), a tube, mandrel or otherstraightening mechanism (not shown) may be used to temporarilystraighten the elongate body. For example, a rigid tube or mandrel maybe placed in one or more lumens of elongate body (2100), which maytemporarily straighten any curved sections. Straightening may occurduring delivery (e.g., when used in conjunction with a left atrialappendage ligation procedure, before the pericardial space is reached),and the straightening mechanism may be withdrawn at any point to allowelongate body (2100) to return to its original configuration. Thestraightening mechanism may be made of any suitable material (e.g., arigid plastic, stainless steel, a combination thereof, etc.).

In other variations, one or more pre-curved tubes or mandrels may beinserted into elongate body (2100) to create one or more curvedsections. In still other variations, one or more pull wires may bedisposed in, on, or around elongate body (2100) and may cause elongatebody (2100) to flex or bend when one or more of the pull wires ispulled, pushed or otherwise manipulated. It should be further understoodthat any of the devices described here may be configured forsteerability, or may be configured for robotic use (e.g., configured foruse with one or more robotic or otherwise automated devices).

Lumens

The elongate bodies described here may have any suitable number oflumens. It should be appreciated that when the term “lumen” is usedherein, it may be used to describe any bore or passageway extendingthrough a length of the elongate body or other portion of the closuredevice. It should be appreciated that a lumen need not be entirelyenclosed (i.e., the lumen may comprise one or more slots, slits, gaps orother openings along some or all of the length of the lumen). Elongatebody may comprise one, two, three, four, or five or more lumens. Some orall of the lumens may extend entirely through the elongate body (i.e.,from the proximal end of the elongate body to the distal end of theelongate body). Other lumens may pass through only a portion of theelongate body (e.g., from one end to an intermediate point along theelongate body, or between two intermediate points along the elongatebody). For example, in the variation shown in FIG. 21, third lumen(2110) passes from the proximal end of the elongate body (2100) to anintermediate point along the length of the elongate body (2100). In thisvariation, one or more guidewires, visualization devices, or workingdevices (not shown) may be passed through third lumen (2110).

The various components of the snare loop assembly may be housed withinany lumen or lumens of the elongate body. For example, in somevariations, all components of the snare loop assembly may be housed in asingle lumen. In other variations, different portions of the snare loopassembly may be at least partially housed in different lumens. Forexample, in some variations, the elongate body may comprise at least twolumens. In these variations, the free end of suture loop may pass to thehandle portion through a first lumen, while the free end of the snaremay pass to the handle portion through a second lumen. In variationswhere the suture loop has excess suture housed within the elongate body,as described in more detail below, this excess suture may be housed inany suitable lumen. For example, in some variations, the excess suturemay be held in the same lumen as the free end of the suture loop, in thesame lumen as the free end of the snare, or in an altogether differentlumen.

In some instances, one or more of the lumens of the elongate body may beat least partially divided into one or more sub-lumens. Specifically, alumen may be split into two or more sub-lumens along a portion of thelength of that lumen. In some of these variations, a piece of separationtubing may be used to divide a lumen into two or more sub-lumens. FIGS.22A-22D illustrate several variations of separation tubing suitable foruse with the closure devices described here. Specifically, FIGS. 22A and22B show a perspective view and a top view, respectively, of onevariation of separation tubing (2200). In this variation, separationtubing (2200) may comprise first (2202) and second (2204) lumensextending therethrough. When placed inside of a lumen of the elongatebody (not shown), the first (2202) and second (2204) lumens ofseparation tubing (2200) may act as sub-lumens within the lumen of theelongate body. In this way, the separation tubing (2200) may allow for alumen to be a single passageway along one length of the elongate bodyand two or more separate passageways along another length of theelongate body.

It should be appreciated that although shown in FIGS. 22A and 22B ashaving two lumens ((2202) and (2204)), separation tubing (2200) mayinclude any suitable number of lumens (e.g., one, two, three, or four ormore). In this way, a lumen of the elongate body may be subdivided intoany suitable number of sub-lumens along the length of the separationtubing. It should be noted that in some variations, the separationtubing may only have a single lumen passing therethrough. In thesevariations, the separation tubing may not divide a lumen into multiplesub-lumens, but instead may alter the size and/or shape of the lumenalong a portion thereof. It should also be appreciated that some or allof the lumens of the separation tubing (2200) may only pass through aportion of the separation tubing.

In other variations, a piece of separation tubing may include one ormore grooves or channels. These grooves or channels may form afully-enclosed sub-lumen when placed inside of a lumen of an elongatebody. For example, FIGS. 22C and 22D illustrate one such variation ofseparation tubing (2206). Specifically, FIG. 22C shows a perspectiveview of separation tubing (2206), which comprises lumen (2208) andchannel (2210) along an outer surface of separation tubing (2206). Whenseparation tubing (2206) is placed inside of a lumen (2211) of anelongate body (2212), as shown in a top view in FIG. 22D, channel (2210)may form an enclosed lumen which may defined in part by the separationtubing (2206) and in part by the lumen wall. It should be appreciatedthat the separation tubing described here may comprise any suitablenumber and combination of channels and/or lumens.

In some variations it may desirable to configure the separation tubingto allow one or more components of the snare loop assembly to bereleased therethrough. For example, in some instances a portion of thesuture loop may be threaded through two or more lumens/channels of asection of separation tubing, as will be described in more detail below.In order to release the suture loop from the device, it may be necessaryto remove any excess suture from separation tubing without undoing orbreaking the suture loop. Thus, in some variations, the separationtubing may comprise one or more separation regions (not shown) betweentwo or more lumens, channels, or combinations thereof. The separationregions may be constructed in any suitable manner, such as thosedescribed above with respect to the retention members. For example, insome variations the separation region may comprise a perforated regionadapted to perforate and allow suture to pull therethrough as the sutureloop is tightened. Alternatively, in some variations the separationregion may be a thin-walled or other type of weakened region that may beconfigured to tear or otherwise break upon the application of force froma suture or other device component.

Tips

The elongate body generally comprises a tip portion at the distal endthereof. In some variations, the tip of the elongate body may be formedseparately from the elongate body, and may be attached to the bodyduring assembly of the device. In other variations the tip portion maybe formed integrally with the elongate body as a unitary device. The tipportion may serve a number of useful functions for closure device. Insome instances, the tip may be configured to be atraumatic, which mayact to reduce the risk of damaging tissue as the proximal end of theelongate body is moved within the body. In other instances, the tip mayallow certain portions of the snare to pass through elongate body whileholding other portions in place relative to elongate body, as will bedescribed in more detail below.

The tip portion may have the same number of lumens as the elongate body,but need not. Indeed, in some variations, the tip portion may divide oneor more lumens of the elongate body into two or more sub-lumens. In someof these variations, the tip portion may house at least one portion of apiece of separation tubing. In other variations, the tip portion mayalter the size or shape of one or more lumens of the elongate body.

FIGS. 23A-23C show the distal end of one illustrative variation ofclosure device (2300). Specifically, FIG. 23A shows a front view of tip(2302) of elongate body (2304). As can be seen there, tip (2302) maycomprise first sub-lumen (2305), second sub-lumen (2306), and thirdsub-lumen (2308). FIG. 23B shows a cross-sectional side view of elongatebody (2304) and tip (2302). As shown there, first (2305) and second(2306) sub-lumens may exit into a first lumen (2310) of elongate body,while third sub-lumen may exit into a second lumen (2312).

In some variations, one sub-lumen may be configured to at leastpartially house a suture knot of the suture loop. For example, secondsub-lumen (2306) shown in FIG. 23B may comprise a knot-receiving recess(2316) with a first cross-sectional area, and a second section (2318)with a second cross-sectional area. A suture knot (2320) of a sutureloop (2330) may be placed in knot-receiving recess (2316) of secondsub-lumen (2306), as shown in FIG. 23C. A free end of suture loop (2330)may pass through second section (2318) into first lumen (2310) ofelongate body (2304). Additionally, the cross-sectional area ofknot-receiving recess section (2316) may be different (e.g., smallerand/or differently shaped) from the cross-sectional area of the secondsection (2318) such that the suture knot (2320) is unable to pass fromknot-receiving recess section (2316) into second section (2318). In thisway, the suture knot (2320) may be prevented from moving proximally intothe elongate body (2304). Additionally, because suture knot (2320) maybe housed at least partially in the knot-receiving recess (2316) ofsecond sub-lumen (2306), suture knot may be prevented from pulling intothird sub-lumen (2308) when excess suture is pulled into elongate body(2304), as will be described in more detail below.

FIG. 23C also illustrates how other components of a snare loop assembly(2324) may be disposed relative to tip (2302). As shown there, snareloop assembly (2324) may comprise snare (2326), suture loop (2330), andretention member (2328). Retention member (2328) may releasably connecta portion of snare (2326) and suture loop (2330). A free end of sutureloop (2330) may pass through second sub-lumen (2306) and first lumen(2310) to a handle portion (not shown), while an amount of excess suture(2330) may be housed within third-sub lumen (2308) of tip and secondlumen (2312) of elongate body. At least a portion of this excess suture(2330) may be held within the elongate body by one or more suturemanagement features (not shown) described below. Additionally, one endof snare may be fixed, temporarily or permanently, at least partiallywithin first sub-lumen (2305), while a free end of snare (2326) may bemoved at least partially through third sub-lumen (2308) of tip andsecond lumen (2312) of elongate to open and close the snare loopassembly (2324).

In variations where the tip of an elongate body comprises aknot-receiving recess, it may be desirable to eject or move the sutureknot from the recess during or prior to tightening of the suture loop.Moving a suture knot out of the recess may improve the ability of thesuture loop to tighten around tissue by improving knot placementrelative to tissue. A suture knot may be displaced from the recess inany suitable manner. For example, FIGS. 24A and 24B illustrate twosuitable variations by which a suture knot may be advanced from aknot-receiving recess. In a first variation, closure device (2400) maycomprise a balloon (2402) or other expandable structure disposed in aknot-receiving recess (2406), as illustrated in FIG. 24A. Suture knot(2408) of suture loop (2410) may be at least partially housed inknot-receiving recess (2406) when balloon is collapsed. When balloon(2402) is expanded, it may displace at least a portion of suture knot(2408) from the knot-receiving recess (2406). In another variation,closure device (2412) may comprise a pusher (2414) at least partiallydisposed in a knot-receiving recess (2416), as shown in FIG. 24B. Inthis variation, pusher (2414) may be advanced within knot-receivingrecess (2416) to push at least a portion of suture knot (2418), and insome instances the entire suture knot (2418), from the knot-receivingrecess (2416).

In other variations of the closure devices described here, the tipportion may comprise a distal recess. FIGS. 25A-25D illustrate one suchvariation of tip (2500). FIG. 25A-25C show a perspective view, a frontview, and a cross-sectional side view of tip (2500). Shown there isproximal recess (2502) for receiving a distal end of the elongate body(not shown), distal recess (2504), first sub-lumen (2506), secondsub-lumen (2508), and third sub-lumen (2510). While shown in FIGS.25A-25C as being formed separately from the elongate body, it should beappreciated that the tip may be formed integrally with the elongatebody.

FIG. 25D illustrates a cross-sectional side view of one instance of howtip (2500) may be incorporated into a closure device (2512). Shown thereis tip (2500) attached to elongate body (2514). As shown there, elongatebody (2514) may comprise a first lumen (2516) and a second lumen (2518),and may be placed within the proximal recess (2502) of tip (2500). First(2506) and second (2508) sub-lumens may exit into first lumen (2516),while third sub-lumen may exit into second lumen (2518).

Closure device (2512) may further comprise separation tubing (2520) thatmay be disposed partially in third sub-lumen (2510) of tip (2500) andsecond lumen (2518) of elongate body (2514), and may divide the lumeninto sub-lumens (2522) and (2524). Also shown in FIG. 25D is snare loopassembly (2526) comprising snare (2528), suture loop (2530), andretention member (2532). One end (2534) of snare (2528) may be fixedlyattached to tip (2500) via first sub-lumen (2506) or may be attached inlumen (2516) through sub-lumen (2506), while a free end of the snare maybe advanced or withdrawn through sub-lumen (2524) of separation tubing(2520). Similarly, a free end (2536) of suture loop (2530) may passthrough second sub-lumen (2508) of tip (2500), while a portion of excesssuture of suture loop (2530) may be housed in sub-lumens (2522) and(2524) of separation tubing (2520).

Suture knot (2538) may be housed in distal recess (2504). Additionally,second sub-lumen (2508) of tip (2500) and sub-lumen (2522) of separationtubing (2520) may be sized such that suture knot (2538) is unable topass into either sub-lumen, thereby preventing suture knot (2538) frombeing pulled or pushed into the elongate body (2514). Additionally, byplacing the ends of the suture knots against the entrances to thesesub-lumens, the suture loop (2530) may be tightened around tissue whileminimizing the amount of tissue that may be pulled into suture knot(2538) as the suture loop (2530) is tightened.

Excess-Suture Management

In operation of the closure devices, it may be desirable to be able toopen and close a snare loop assembly without prematurely releasing thesuture loop from the snare assembly. Because the size of the continuousaperture defined by the snare loop assembly changes as the snare loopassembly is opened and closed, it may be necessary for the size of thesuture loop to change in order to accommodate this change in aperturesize and to prevent the suture from being prematurely released from thesnare loop assembly. In some variations, opening the snare loop assemblymay pull suture through a slip knot to increase the size of the sutureloop. This may, however, provide sufficient force to the suture loop tocause the suture to break or sever. To help prevent this undesirableoutcome, the suture loop may be sized such that the suture loop is aslarge as or larger than the size of the aperture defined by the snareloop assembly when the snare loop assembly is in an open configuration.Thus, when the snare loop assembly is opened to a deployedconfiguration, the suture loop can assume a similar size without needingto advance additional suture through the suture knot. Pre-sizing thesuture loop to such a size, however, may result in extra slack in thesuture loop when the snare loop assembly is in a closed configuration.To help prevent the excess suture from getting entangled with or caughton anatomical structures, instruments, or other obstructions, some orall of the slack in the suture loop may be held inside of the elongatebody when the snare loop assembly is opened and/or closed.

As such, the closure devices described here may comprise one or moreexcess-suture management features, which may be used in any suitablemanner. In some instances, the feature may be configured to apply aforce to the excess suture when the device is an open and/or a closedconfiguration. This force may act to pull the excess suture into theelongate body or may temporarily prevent excess suture from exiting theelongate body. Additionally, this force may act to prevent the excesssuture from knotting or bunching up, which may potentially affect deviceperformance. The following is a discussion of a number of differentpotential suture management features suitable for use for the closuredevices described here. It should be appreciated that the closuredevices described here may comprise any combination of these suturemanagement features.

Suture Hooks

In some variations, a suture hook may be used to hold the excess suturewithin the elongate body. FIG. 2 shows one such variation of a snareloop assembly (200) having suture hook (202). Also shown there is snare(204), suture loop (206) having suture knot (208), and retention member(210). As illustrated in FIG. 2, suture hook (202) may hold excesssuture from suture loop (206) within an elongate body (not shown). Invariations in which the elongate body has multiple lumens, suture hook(202) may hold excess suture in any suitable lumen.

In some variations the proximal end of the suture hook may be able tomove relative to the elongate body when snare is advanced from orwithdrawn through or within the elongate body. FIG. 10 shows across-sectional side view of a portion of closure device (1000)comprising elongate body (1002) with lumen (1004) disposed therethrough,and connected to interconnect (1006) of a handle (not shown). It shouldbe appreciated that, although shown in FIG. 10 as having only one lumen(1004) disposed therethrough, elongate body (1002) may have any numberand configuration of lumens as described above. Also shown in FIG. 10 isa portion of snare (1008) attached to hypotube (1009) and suture hook(1010) engaging a portion of suture loop (1012). As described above,snare (1008) may be advanced or withdrawn through or within elongatebody (1002) to open or close a snare loop assembly (not shown).

When snare (1008) is advanced and snare loop assembly is opened, sutureloop (1012) may pull suture hook (1010) toward the distal end of theelongate body (1002) to release some of the excess suture from theelongate body (1002) or to allow some of the excess suture to advancewithin the elongate body (1002). In some variations, suture hook (1010)comprises a spring (1014). Spring (1014) may stretch when suture hook(1010) moves toward the distal end of the elongate body (1002).Conversely, closing the snare loop assembly may reduce the force appliedto suture hook (1010) by suture loop (1012), which may allow the returnforce of the spring (1014) to pull suture hook (1010) proximally. This,in turn, may pull any excess suture back into or through a portion ofelongate body (1002). Because excess suture is released from elongatebody (1002) when the snare loop assembly is opened and withdrawn intoelongate body (1002) when snare loop assembly is closed, the suture loop(1012) may be maintained at the same size as the snare loop assembly.Additionally, because the excess suture is doubled back into theelongate body when held by suture hook (1010), suture hook (1010) needonly to be configured to move half as much as snare (1008) in order tomaintain the suture loop (1012) at the same size as snare loop assembly.

It should be appreciated that although shown in FIG. 10 as having oneend attached to suture hook (1010) and the other end attached tointerconnect (1006) (which will be described in more detail below),spring (1014) may be attached to any suitable portion or portions of theclosure device (1000). In some variations, the spring may be attached toone or more elements of the handle, as will be described in more detailbelow. In other variations, the spring may be attached to one or moreportion of the elongate body (1002). In still other variations, suturehook (1010) does not comprise a spring at all. In some of thesevariations, at least a portion of the suture hook (1010) may be capableof stretching or otherwise deforming to allow excess suture to be pulledout of elongate body (1002). For example, suture hook (1010) maycomprise an elastic material or combination of materials that arecapable of both stretching and returning to an unstretched state. Inthese instances, as snare loop assembly opens, the elastic material ormaterials may stretch to allow excess suture to be pulled out of orthrough a portion of elongate body (1002). When snare loop assembly isclosed, the suture hook (1010) may return to its unstretched state, andmay thereby pull the excess suture back into or through a portion of theelongate body (1002).

In variations where excess suture from suture loop (1012) is held withinthe elongate body by suture hook (1010), an additional step may berequired to release suture loop (1012) from snare loop assembly. Oncesnare loop assembly is advanced over a target tissue and closed over thetissue, there may be excess suture from suture loop (1012) held in theelongate body by suture hook (1010). Before suture loop (1012) can bereleased from the snare loop assembly, this slack may first need to beremoved. To achieve this, the excess suture may be pulled through asuture knot (not shown) to reduce the size of suture loop (1012). Insome variations, suture hook (1010) may be configured to deform oncesufficient force is applied thereto. Furthermore, in some variationssuture hook (1010) comprises a stop (1016) that prevents suture hook(1010) from moving distally beyond a certain point. Thus, as suture iswithdrawn through suture knot and the size of suture loop (1012)decreases, suture loop (1012) places an increasing force on suture hook(1010). Suture hook (1010) may move toward the distal end the elongatebody (1002) until stop (1016) engages interconnect (1006). It should benoted that stop (1016) may engage any suitable structure in closuredevice (1000). When stop (1016) engages interconnect (1006), suture hook(1010) is held in place and eventually the force applied by suture loop(1012) may cause the end of suture hook (1010) to deform and release theremaining excess suture.

After suture loop (1012) has been released from suture hook (1010) andthe excess suture has been removed from suture loop (1012), anyadditional suture that is pulled through suture knot may begin torelease suture loop (1012) from the snare loop assembly. If the snareloop assembly is closed around tissue before releasing suture loop(1012), any excess suture may be held within the elongate body (1002).Thus, any excess suture removed from the suture loop (1012) is housedwithin the elongate body (1002). Because this suture is housed withinthe elongate body (1002), it will not rub against or otherwise makecontact with tissue disposed outside of the elongate body (1002).Additionally, as the suture loop (1012) is released from the snare loopassembly, the suture is released directly into contact with the tissue.Thus, a user may both remove excess suture from the suture loop (1012)and release the suture loop (1012) from the snare loop assembly withoutrubbing or sliding against the tissue. Because tissue may be damagedwhen suture slides or rubs against tissue, the closure devices describedhere may help minimize damage caused to tissue in this way. Once thesuture loop (1012) is completely separated from the snare loop assembly,it may be tightened to ligate the target tissue.

As shown in FIG. 10, snare (1008) and suture hook (1010) may be disposedin the same lumen (1004) of elongate body (1002), but need not be. Invariations where the snare (1008) is disposed in the same lumen (1004)as suture hook (1010), there may be a risk of the snare (1008) becomingentangled with the suture hook (1010). Additionally, because the suturehook (1010) need only move half as much as snare (1008) when opening andclosing the snare loop assembly, the snare (1008) may rub against spring(1014), which may in turn cause spring (1014) to rub against the innerwall of lumen (1004). This friction may impede the actuation of theclosure device (1000), and thus increase the force a user must provideto actuate the device.

In some variations, the closure device may be configured to help preventthe suture hook from tangling with the snare. FIG. 11 shows one suchvariation of a middle portion of closure device (1100). Shown there iselongate body (1102) attached to interconnect (1104), hypotube (1106),snare (1108), spring (1110), suture hook (1112), sleeve (1114), andsuture loop (1116). The free end of snare (1108) may be attached tohypotube (1106), as described above. Additionally, suture hook (1112)may be attached to hypotube (1106) via spring (1110). Spring (1110) mayadditionally be disposed around snare (1108), which may help preventspring (1110) from tangling with snare (1108). Additionally, this mayreduce the amount of space taken up by snare (1108) and spring (1110),which may, in turn, allow snare and spring to be placed within a smallerlumen without adding to the amount of rubbing that occurs between thespring and the inner wall of lumen.

Sleeve (1114) may also act to help prevent tangling between suture hook(1112) and snare (1108). Sleeve (1114) may have two or more lumens.Suture hook (1112) may pass through one lumen, while snare (1108) maypass through a separate lumen. In some variations, sleeve (1114) may beattached to snare (1108). Sleeve (1114) may be attached in any suitablemanner (e.g., bonding, welding, mechanical attachment, etc.). In thesevariations, sleeve (1114) may act as a stop to help release suture loop(1116) from suture hook (1112). As excess suture is removed from sutureloop (1116), as described above, spring (1110) may stretch until itcomes into contact with sleeve (1114). Once in contact with sleeve,spring (1110) may be held in place while the force exerted on suturehook (1112) by suture loop (1116) may cause suture hook (1112) todeform, and may thereby release suture loop (1116) from suture hook(1112).

Separation Tubing

In some instances it may be desirable to maintain excess suture withinthe elongate body without the need for a suture hook. Under certaincircumstances, as a portion of the elongate body is advanced into orthrough the body, one or more portions of the elongate body may bend orflex to allow the snare loop assembly to reach a target location.Bending or flexing the elongate body, however, may impede movement ofthe suture hook or spring, which may potentially impede the snare hook'sability to maintain excess suture loop within the elongate body. Thus,it may be desirable to have a suture maintenance feature that is locatedin a distal portion of the elongate body.

As such, in some variations of the closure devices described here, oneor more pieces of separation tubing may be used to help maintain excesssuture within the elongate body, and may thereby limit the exposure orrelease of excess suture out of the elongate body. FIGS. 26A and 26Bshow cross-sectional side views one such variation of a closure device(2600). Shown there is lumen (2602) with separation tubing (2604)disposed therein. Separation tubing (2604) may divide lumen (2602) intoa first sub-lumen (2606) and a second sub-lumen (2608). Closure device(2600) may comprise a snare loop assembly (2610), which may comprisesnare (2612), suture loop (2614), and retention member (2616). As shownin FIGS. 26A and 26B, suture from suture loop (2614) may pass throughfirst sub-lumen (2606) into lumen (2602), where it may be connected tosnare (2612) via retention member (2616). Snare (2612) may be advancedor withdrawn through second sub-lumen (2608) to open or close the snareloop assembly, respectively. When snare loop assembly (2610) is in aclosed configuration, as shown in FIG. 26A, excess suture from sutureloop (2614) may be held in snare lumen (2602) and first sub-lumen(2606). When snare is advanced to open the snare loop assembly, some ofthe suture held within the snare lumen may be advanced into the secondsub-lumen (2608) to allow the snare loop assembly to open, as shown inFIG. 26B. The presence of separation tubing, however, may prevent theexcess suture from being pushed or pulled out of the tip of the closuredevice.

When separation tubing is employed to maintain excess suture withinelongate body, it may be necessary for the separation tubing to compriseone or more separation regions to release the excess suture from theelongate body. These separation regions, as described in more detailabove, may allow suture to pass therethrough during release of thesuture loop. Specifically, as excess suture is removed from the sutureloop (i.e., as suture is pulled through the suture knot to tighten thesuture loop), the suture may be pulled through the separation regions,allowing the excess suture to span the space between the sub-lumens ofthe separation tubing.

It should be appreciated that any suitable piece of separation tubing asdescribed in more detail above may be used to maintain excess suturewithin the elongate body. It should also be appreciated that separationtubing may be used in conjunction with a suture hook, as describedabove, or one or more additional excess-suture management features. Forexample, in some instances separation tubing may be used in conjunctionwith one or more suture tubes. Generally, a suture tube has a first endthat may be connected to the separation tubing, a second end that may beconnected to a portion of the snare loop assembly, and may temporarilyhold excess suture therein. The suture tube may be made from anysuitable material (e.g., pebax, tecothane, nylon, or the like), and maycomprise one or more separation regions which may allow the excesssuture to be removed from the suture tube.

FIG. 27 shows a partial cutaway view of one such variation of a closuredevice (2702) comprising elongate body (2701), separation tubing (2704)and a suture tube (2705). Shown there is separation tubing (2704), whichdivides lumen (2700) into first sub-lumen (2706) and second sub-lumen(2708). Also shown there is snare loop assembly comprising snare (2712),suture loop (2714), and retention member (2716) at least temporarilyconnecting snare (2712) and suture loop (2714). As shown in FIG. 27,suture tube (2705) may releasably house a portion of suture loop (2714).One end of suture tube (2705) may be attached to the separation tubing(2704), and the other end may be attached to a portion of the snare loopassembly (e.g., attached to snare (2712) or retention member (2716)). Byvirtue of this attachment, one end of the suture tube (2705) may befixed relative to the closure device (2702) while the other end may movewith snare (2712) and closure element (2716) as the snare loop assemblyis moved between a closed configuration and an open configuration.

When placed in lumen (2700), suture tube (2705) may double back uponitself at bend (2718). In this way, the portion of suture loop (2714)temporarily housed in suture tube (2705) may be held in the doubled-backsuture tube (2705), which may help prevent the excess suture held withinlumen (2700) from bunching. The position of bend (2718) may move as thesnare loop assembly is changed between opened and closed configurations.Additionally, in some instances the suture tube (2705) may have atendency to return to an unbent shape, which may also give the suturetube (2705) tendency to twist and kink at points other than bend (2718).As such, suture tube may comprise one or more features that may helpreduce twisting or kinking. For example, in some variations, tubecomprises a plurality of cut or slits that may act as relief areas.FIGS. 28A and 28B show one such variation of suture tube (2800). FIG.28A shows suture tube (2800) comprising v-shaped cuts (2802) along oneside thereof. Each v-grooved cut (2802) reduces the rigidity of suturetube (2800) along that side, and may make the suture tube (2800) morelikely to bend or flex at that cut (2802). Thus, when suture tube (2800)is placed within a lumen (2804), as shown in FIG. 28B, and doubles backat bend (2806), some of the v-shaped cuts (2802) may be essentiallyclosed. As such, the v-shaped cuts (2802) may reduce the straighteningforce of the suture tube (2800), and may thereby alter the tendency ofthe suture tube (2800) to kink or twist. While shown in FIGS. 28A and28B as being v-shaped, the cuts may be any suitable shape (e.g.semi-circular, semi-oval, etc.).

In other variations, the suture tube may comprise one or morestrengthening members that may affect the rigidity of one or moreportions of the suture tube. FIG. 29 illustrates a cross-sectional viewof one such variation of suture tube (2900). Shown there is suture tube(2900), comprising suture lumen (2902), two strengthening members(2904), and separation region (2906). The strengthening members (2904)provide extra rigidity to a portion of the suture tube (2900). As such,when suture tube (2900) is doubled-over for placement in a snare lumen,the side of suture tube (2900) containing the strengthening member(2904) will have more resistance to bending, which may allow suture tube(2900) to better resist twisting and kinking. Additionally,strengthening members (2904) may increase the column strength of thesuture tube (2900), such that the tube may be more easily moved as thesnare is advanced or retracted. Strengthening members may be anysuitable structures, such as, for example a wire made from a nickeltitanium alloy, steel, a polymer, or the like. While shown in FIG. 29 ashaving two strengthening members (2904), it should be appreciated thatthe suture tube may comprise any suitable number of strengtheningmembers (e.g., one, two, or three or more)

Pulley Suture

In still other variations, the snare loop assembly may comprise a secondsuture, a pulley suture, that may engage a portion of the suture loop tohelp hold excess suture. Generally, one end of the pulley suture may befixedly attached to a portion of the closure device (e.g., the handle orthe elongate body) while the other end may be temporarily or permanentlyattached to the snare loop assembly. In some variations, the body of thepulley suture may be looped around or doubled back over a portion ofsuture loop to help hold a portion of the suture loop in the elongatebody. FIGS. 30A-30D depict one variation of closure device (3000)comprising a pulley suture (3002) that may be used to hold a portion ofa suture loop (3010) within a lumen (3004) of an elongate body (3006).Shown in FIG. 30A is snare loop assembly (3008) comprising suture loop(3010), snare (3012), retention member (3014), first suture lock (3016),second suture lock (3018), first separation tubing (3020), and secondseparation tubing (3022). While shown in FIG. 30A as having first (3020)and second (3022) separation tubing segments, closure device (3000) maycomprise any number of separation tubing segments (e.g., zero, one, two,or three or more). Additionally, for clarity's sake first (3020) andsecond (3022) separation tubing segments are not shown in FIGS. 30B and30C.

As mentioned above, one end (not shown) of pulley suture (3002) may befixedly attached to a portion of the handle (e.g., a suture fob, as willbe described in more detail below) while the other end may betemporarily attached to snare (3012) via second suture lock (3018)(suture locks will be described in more detail below). Pulley suture(3002) may also be doubled-back over a portion of suture loop (3010)between knot (3024) and second suture lock (3018), as shown in FIGS.30A-30C. This engagement may allow excess suture to be advanced throughelongate body (3006) when snare (3008) is advanced (as shown in FIG.30B), while pulling excess suture distally into elongate body when snare(3008) is retracted (as shown in FIG. 30C). Because both suture loop(3010) and pulley suture (3002) are each temporarily attached to snare(3008) (by virtue of first (3016) and second (3018) suture locks,respectively), the sutures may be moved the same distance when snare(3008) is moved. This movement may also advance or retract the point ofoverlap between the two sutures when the snare is advanced or retracted,respectively.

In order to release the suture loop (3010) from the closure device(3000), it may be necessary to terminate the engagement between thepulley suture (3002) and suture loop (3010). This engagement may beterminated in any manner. In some variations the pulley suture may bereleased from suture lock and removed from the elongate body by pullingon one end of the pulley suture (3002). Indeed, pulley suture (3002) maybe configured to pull out of or otherwise separate from the secondsuture lock (3018) upon application of a certain force to the pulleysuture. As shown in FIGS. 30A-30C, pulley suture (3002) may double backas it enters second suture lock (3018). This may help release pulleysuture (3002) from second suture lock (3018) as the change in directionmay increase the shear force applied by the pulley suture (3002) to thesecond suture lock (3018). Additionally, first suture lock (3016) may beconfigured to release suture loop (3010) when a certain force is appliedto the suture loop. To help prevent premature release of the suture loop(3010) from retention member (3014), the closure device (3000) may beconfigured such that the release force for the second suture lock (3018)is less than the release force for the first suture lock (3016), butneed not be.

In order to release pulley suture (3002) from snare (3008), one end ofpulley suture (3002) may be attached to one or more portions of thedevice's handle. For example, FIG. 30D shows one variation of a portionof handle (3024) of closure device (3000). As shown there, an end ofpulley suture (3002) and an end of suture loop (3010) may be attached tosuture fob (3026). While shown in FIG. 30D as attached to the samesuture fob, it should be appreciated that pulley suture (3002) andsuture loop (3010) need not be attached to the same handle component. Invariations where the pulley suture (3002) and the suture loop (3010) areattached to the same handle component, such as the variation shown inFIG. 30D, the suture loop (3010) may comprise slack/excess suture insideof the handle (3024). Thus, when suture fob (3026) is pulled away fromhandle (3024), the pulley suture (3002) may be placed under tensionbefore the suture loop (3010) is placed under tension. In this way, asthe suture fob (3026) is pulled, the closure device (3000) may beconfigured to release the pulley suture (3002) from second snare lock(3018) prior to tightening and releasing the suture loop (3010).

FIG. 15 shows another variation of closure device (1502) comprising apulley suture (1504). In this variation, pulley suture (1504) may bereleasably connected to suture loop (1506) via deformable link (1508).One end of pulley suture (1504) may be attached to snare (1510) viafirst suture lock (1512), while the other end of the pulley suture(1504) may be fixedly attached to any suitable portion of the device(e.g., one or more portions of the handle or the elongate body). As inthe other variations described above, pulley suture (1504) may beadvanced or withdrawn with snare (1510) to help hold a portion of thesuture loop (1506) inside of elongate body (1514).

To release the engagement between pulley suture (1504) and the sutureloop (1506), the suture loop (1506) may be pulled away from the pulleysuture (1504). This may be done in any suitable manner, such as, forexample, tightening the suture loop (1506) or pulling one end of pulleysuture (1504) relative to the suture loop (1506). As the suture loop(1506) and pulley suture (1504) are pulled away from each other, the twosutures may apply one or more forces to the deformable link (1508).These forces may cause the deformable link (1508) to deform, which mayrelease the engagement between the suture loop (1506) and pulley suture(1504).

Force Reduction

In some instances, when a suture hook or other suture maintenancefeature pulls and holds excess suture in an elongate body, it may exertone or more forces on the suture loop. This force applied to the sutureloop may, in some instances, cause the suture loop to prematurelydisengage from the snare loop assembly. This is illustrated in FIG. 12.Shown there is the distal end of closure device (1200) comprising snareloop assembly (1202) and suture hook (1204). Snare loop assemblycomprises suture loop (1206) with suture knot (1208) and releasablycoupled to snare (1210) via retention member (1212). When suture loop(1206) is pulled into an elongate body (not shown) by suture hook(1204), suture hook (1204) may place one or more tensile forces (1214)on the suture of suture loop (1206). These tensile forces may betranslated into inwardly directed forces (1216) in the portion of sutureloop (1206) disposed within snare loop assembly (1202). These inwardlydirected forces (1216) may cause suture loop (1206) to disengage thesuture loop (1206) from the retention member (1212), thereby releasingsuture loop (1206) from snare loop assembly (1202) prematurely.

In order to prevent this problem, the snare loop assembly may compriseone or more suture locks. FIGS. 13A-13C illustrate one such variation ofa closure device (1300). FIG. 13A shows a cross-sectional side view ofclosure device (1300) comprising snare loop assembly (1302), suture hook(1304), and suture lock (1306). Snare loop assembly (1302) may comprisesuture loop (1308) with suture knot (1310) and coupled to snare (1312)via retention member (1314). FIG. 13B shows a front view of suture lock(1306). Shown there is suture lock (1306) comprising first lumen (1316),second lumen (1318), and slit (1320). Generally, at least a portion ofsnare (1312) may pass through first lumen (1316), while at least aportion of suture loop (1308) may pass through second lumen (1318). Insome variations, force-reducing element (1306) may be attached to snare(1312) via first lumen (1316).

Generally, second lumen (1318) of force-reducing element (1306) may beconfigured to compress at least a portion of suture loop (1308). Becausesuture generally comprises a braided material disposed around a strengthmember, portions of a suture may be compressed without significantlyaffecting its strength. Second lumen (1318) may have a cross-sectionalarea that is smaller than the cross-sectional area of the suture. Thus,a portion of suture loop (1308) may be advanced through or otherwiseplaced in the second lumen (1318), and the narrow cross-sectional areaof second lumen (1318) may act to compress the portion of suture loop(1308) disposed within second lumen, as shown in FIG. 13C. Thecompressed portion of suture loop (1308) may cause the suture loop(1308) to resist being pulled or pushed through force-reducing element(1306). More specifically, the uncompressed portions of suture loop(1308) may abut against the outer surface of the force-reducing element,and this abutment may resist movement of suture through the second lumen(1318).

Compression of a portion of suture loop (1308) may help prevent sutureloop (1308) from prematurely releasing from snare loop assembly (1302).As described above with respect to FIG. 12, tensile forces placed on asuture loop may be translated into one or more forces that may cause asuture loop to disengage from a snare loop assembly. A force-reducingsuture lock (1306) may help reduce or eliminate the forces applied tothe portion of suture loop held by snare loop assembly (1302). Morespecifically, the compression of the portion of suture loop (1308)disposed within second lumen (1318) may prevent or reduce thetransmission of the tensile force through force-reducing element (1306).As noted above, the compression of suture loop (1308) may cause thesuture loop (1308) to resist movement through force-reducing element(1306). Thus, when suture hook (1304) applies a tensile force to sutureloop (1308), as described above, this tensile force may attempt to pullsuture through force-reducing suture lock (1306), but any such movementis resisted by the compression caused by force-reducing element (1306).As a result, some or all of the tensile force is, in effect, dissipatedby trying to pull suture through force-reducing suture lock. This, inturn, may reduce or completely remove any force experienced by thesuture on the other side of force-reducing element. Thus, force-reducingsuture lock (1306) may reduce or remove the forces that may cause thesuture loop (1308) to prematurely release form the snare loop assembly(1302).

Force-reducing suture lock (1306) may comprise one or more slits (1320)or other openings. These slits may allow suture loop (1308) to passtherethrough when it is ready to be deployed. These slits may have anysuitable configuration, such as those described in U.S. patentapplication Ser. No. 12/055,213. Generally, once suture loop (1308) istightened to remove excess suture from suture loop (1308), the sutureloop (1308) may be tightened further, which may cause a portion of thesuture loop (1308) to pass through the slit or other opening. As suturepasses through the slit, suture loop (1308) may be released fromforce-reducing suture lock (1306).

In some variations, a force-reducing suture lock may be made from one ormore pieces of shrink tubing. In these variations, a portion of thesnare and the suture loop may be threaded through one or more lumens ofthe shrink tubing. One or more stimuli (e.g., heat) may be applied tothe shrink tubing, which may cause the shrink tubing to get smaller.This reduction in size may act to hold and connect suture loop andsnare.

Handles

Handles or proximal controls that are capable of facilitating removal ofexcess suture from a suture loop and releases of suture loop from snareloop assembly are provided. Handles having one or more ergonomicfeatures or configurations to help facilitate and improve the usethereof are also described herein. FIGS. 3A and 3B show a perspectiveview and a cross-sectional side view, respectively, of one suitablevariation of handle (300). FIG. 3A shows a perspective view of handle(300) attached to elongate body (302). Also shown there is strain reliefportion (304), snare lock (306), snare control (308), suture fob (310),and guidewire introducer (312). FIG. 3B shows a cross-sectional bottomview of handle (300). Also shown there is interconnect (314), lockingcollar (316), suture (318) and snare (320). Generally, suture (318) maybe attached to suture fob (310), which may be pulled away from thehandle. Pulling suture fob (310) may tighten the suture loop (notshown), and this tightening may pull excess slack from the suture loop.Once any excess slack has been removed from the suture loop, a user maycontinue to tighten the suture loop to release the suture loop from thesnare loop assembly (not shown). Similarly, snare (320) may be attachedto snare control (308), which may in turn be used to control a snareand/or a snare loop assembly. As snare control (308) is moved proximallyor distally relative to handle (300), a portion of snare (320) may bemoved proximally or distally through elongate body (302). This, in turn,may cause a snare loop assembly to move between an open and a closedconfiguration, as described in more detail above.

While shown in FIG. 3B as having a locking collar (316), handle (300)need not. In variations that include a locking collar (316), lockingcollar (316) may be attached to elongate body (302) and held by handle(300) to help prevent elongate body (304) from being disengaged fromhandle (300). Similarly, while shown in FIGS. 3A and 3B as having astrain relief portion (304), handle (300) need not. In variations thatinclude a strain relief portion (304), the strain relief portion (304)may stretch, compress, or otherwise deform to help reduce the strainplaced on elongate body (304) by handle (300). This deformation may ormay not be reversible. Generally, the strain relief portion (304) may beattached to both handle (300) and elongate body (304). When a forcepushes, pulls, or twists elongate body (304) relative to handle (300),the strain relief portion (304) may resist this movement and thus aportion of the force may cause the strain relief portion to stretch,compress, or otherwise deform as mentioned above. The deformation of thestrain relief portion (304) may act to reduce the relative movementbetween elongate body (304) and handle (300), which may help minimizethe likelihood of the elongate body (304) disengaging from handle (300).Strain relief portion (304) may have any suitable size, shape, orconfiguration.

Additionally, while shown in FIG. 3B as having an interconnect (314),handle (300) need not. In variations that include an interconnect (314),interconnect (314) may be attached to elongate body (304), and may alignthe various lumens of elongate body (304) within handle (300). Forexample, in variations where handle (300) comprises a guidewireintroducer (312), interconnect (314) may align guidewire introducer(312) with a working lumen (not shown) in elongate body (304).Interconnect (314) may align any number of device components with anynumber of lumens in elongate body (304).

While handle (300) is shown in FIGS. 3A and 3B to have a guidewireintroducer (312), it may have any number of introducers or guides forintroducing devices, fluids, or other components into elongate body(304). Indeed, handle (300) may have a guide to introduce one or moreworking devices such as a tissue grasper, a tissue ablator, cuttingtool, visualization device, a combination thereof, or the like, into alumen in elongate body (304). In other variations, handle (300) mayinclude an introducer to provide flushing, drug delivery, vacuum, or thelike through a lumen in elongate body (304).

Furthermore, while shown in FIG. 3A as having a snare lock (306), handle(300) need not. In variations that include a snare lock (306), snarelock (306) may be used to prevent snare control (308) from being movedrelative to handle (300). Thus, in order to manipulate a snare loopassembly (not shown) a user must first depress snare lock (306) torelease snare control (308). Once snare control (308) is released, auser may push snare control distally or pull snare control proximally toopen or close the snare loop assembly. When a user stops depressingsnare lock (306), snare control (308), and with it the snare loopassembly, may again be locked in place. In other variations, handle(300) may have one or more features to prevent snare control (308) frombeing accidentally actuated. In some of these variations, snare control(308) may be configured such that it cannot slide relative to the handleunless a user first depresses the snare control itself. In othervariations, the snare control (308) comprises a button or other controlthat must first be manipulated before the snare control (308) may beactuated. In still other variations, the snare control (308) may befreely actuated, but may be locked into place by depressing either abutton, other control, or the snare control (308) itself.

Once the snare loop assembly is properly closed, suture fob (310) may bedetached from the handle to tighten the suture loop (not shown). Assuture fob (310) is pulled away from handle (300), suture fob (310) maypull suture through a suture knot (knot shown) to tighten the sutureloop. As the suture loop is tightened, any excess suture held in theelongate body may be removed from the suture loop. Once this slack hasbeen removed, the user may continue to pull suture fob (310) todisengage the suture loop from the snare loop assembly. Once disengagedfrom the snare loop assembly, the suture loop may be further tightenedto ligate the enclosed tissue. The direct connection of suture fob (310)to suture (318) may provide tactile feedback to the operator to indicatethe various stages of a closing procedure. More specifically, a user mayexperience different resistances when pulling suture fob (310) that maycorrespond to different stages of suture loop tightening. For example, auser may experience a given resistance when removing excess suture (318)from the suture loop. In variations where the closure device comprises asuture hook (not shown), the resistance may change when the suture (318)is released from the suture hook. Additionally, the resistance maychange once all of the excess suture has been removed from the sutureloop, once the suture loop starts being released from the snare loopassembly, and once the suture loop is completely released from the snareloop assembly.

Additionally, in some variations it may be desirable to ensure that auser may only apply a given force to the suture loop. If a suture loopis tightened too much, it may damage the ensnared tissue. As such, insome variations a suture fob (310) may be configured to break away fromsuture (318) upon application of a predetermined force (for example,between about 8 lbs and about 10 lbs) to suture fob (310). In this way,the device may be configured such that a user may tighten a suture loopusing a suture fob (310) without damaging the ensnared tissue, as thesuture fob (310) may be configured to separate from the suture prior todamaging tissue.

Suture (318) may additionally include one or more visual markers (e.g.,a colored coating) to indicate when the excess suture (318) has beenremoved from the suture loop. For example, a portion of suture (318) mayhave a colored marker located a certain distance from suture fob (310).The distance between the colored marker and the suture fob (310) maycorrespond to the amount of excess suture in the suture loop when thesnare loop assembly is closed. A user may then pull suture (318) out ofhandle (300) using suture fob (310). When the colored marker becomesvisible outside of handle (300) (or through a window in handle (300)), auser may know that the excess suture has been removed. Because theamount of excess suture may be dependent on the size of the loop formedby snare loop assembly, and because the size of the loop formed by snareloop assembly may be changed by snare control (308), in some instancesthe one or more visual markers on the suture (318) may correspond to oneor more visual markers on snare control (308).

Additionally, suture (318) may be connected to suture fob (310) in anysuitable manner. In some variations, such as that shown in FIG. 3B, oneend of suture (318) may be connected directly to suture fob (310). Insome of these variations, suture (318) may pass through a channel insuture fob (310), and may be knotted such that the resulting knotengages suture fob (310). In others of these variations, suture (318)may be clipped, grasped, or otherwise attached to suture fob (310). Inother variations, suture fob (310) may comprise a pulley (not shown)that engages suture (318). In these variations, the end of suture (318)may be attached to another structure in handle (300), such asinterconnect (314), and the pulley may slidably engage the suture (318).Because the suture is doubled-back over the pulley, a user may need topull a suture fob (310) a shorter distance to achieve the same amount oftightening. For example, when a user withdraws a suture fob one inch,the pulley may also be withdrawn one inch. During this withdrawal, thepulley may pull more suture (318) into handle (300). For each inch thatpulley moves, about two inches of suture are pulled into handle (oneinch for each portion of suture (318) on either side of the pulley), andthus a user need only move suture fob (310) half the distance to achievethe same level of tightening.

In some instances, it may be desirable to remove at least a portion ofthe excess suture without having to first disengage the suture fob. Forexample, FIG. 4 shows a perspective view of one variation of handle(400) attached to elongate body (402). Shown there is strain reliefportion (404), suture fob (406), guidewire introducer (408), snarecontrol (410), and suture fob control (412). Generally, snare control(410) may attach to a snare (not shown) to control a snare loop assembly(not shown), as described above. In some variations, snare control (410)may be configured to lock in place when not being actuated. In theseinstances, the snare control (410) may be unlocked in any number ofways, such as by depressing snare control (410) or by depressing a snarelock (not shown). In some of these variations, when snare control (410)or snare lock is no longer being depressed, snare control (410) is againlocked into place.

In the variation shown in FIG. 4, suture fob (406) may be moved into andout of handle (400) by suture fob control (412). Suture fob (406) may beattached to a suture (not shown) in any manner as described above.Generally, the closure device is initially configured such that thesuture fob control (412) is positioned near the distal end of handle(400), and suture fob (406) is entirely contained within handle (400).Suture fob control (412) may have one or more locking features likethose described with respect to the snare control (410) above. Once thesnare loop assembly has been closed around a target tissue using snarecontrol (410), suture fob control (412) may be pulled proximally to theposition shown in FIG. 4, to remove excess suture from the suture loop.Because movement of suture loop handle (412) is limited by the length ofthe track in which it sits, the length of this track may determine theamount of suture that may removed from the suture loop. In othervariations, the handle (400) may comprise one or more features (e.g.,stops) that limit the amount that suture fob control (412) may move.Thus the amount of suture pulled by suture fob control (412) may bedependent on the track in which suture fob control (412) is disposed, aswell as the manner in which the suture is attached to the suture fob(406). As such, handle (400) may be configured to remove a predeterminedamount of excess suture from the suture loop (not shown) when suture fobcontrol (412) is actuated. Once suture fob control (412) has been movedto the position shown in FIG. 4, suture fob (406) may project out of theend of handle (400) and may be disengaged from handle (400). Oncedisengaged, the suture fob (406) may be pulled to remove any remainingexcess suture from the suture loop, and then may pulled to remove thesuture loop from the snare loop assembly. Once the suture loop has beenreleased from the snare loop assembly, the suture fob (406) may be usedto further tighten the suture loop and ligate tissue.

In some variations, a suture fob control has one or more features tohelp facilitate actuation of the suture fob control. FIG. 5 shows onesuch variation of a handle (500). Shown there is handle (500) with snarecontrol (502), suture fob (504), and suture fob controls (506) withextensions (508). Snare control (502) and suture fob controls (506) maywork in any suitable manner as described above. Extensions (508) may beany suitable structure or protrusion attached to, formed in, or formedupon one or more suture fob controls (502) that provide a surface thatcan be grasped, gripped, or otherwise contacted by a user to facilitateactuation of the suture fob controls (506). Extensions may have anysuitable size, shape, configuration, and orientation. For example, inthe variation shown in FIG. 5, extensions (508) are configured to allowa user to hold and actuate the handle (500) in a “syringe-like” fashion.

In other variations, a handle may have one or more alternativemechanisms to help remove excess suture from a suture loop. FIG. 6 showsone such variation of handle (600) comprising snare control (602),suture fob (604), and squeeze grip (606). To remove excess suture from asuture loop, a user may repeatedly compress squeeze grip (606). When auser compresses squeeze grip (606), squeeze grip (606) may pull suturefrom suture loop into handle (600). In some of these variations,compressing squeeze grip (606) may rotate a suture reel (not shown),which may collect suture as it rotates. Once a sufficient amount ofsuture has been removed from the suture loop, suture fob (604) may bedisengaged to release suture loop from the snare loop assembly, asdescribed above.

FIG. 7 illustrates another variation of handle (700). Shown there ishandle (700) comprising snare control (702), suture fob (704), andsuture knob (706). In these variations, suture knob (706) may be rotatedto remove excess suture from a suture loop. In some of these variations,suture knob (706) may rotate a suture reel, which collects suture as itrotates. In other variations, rotating suture knob (706) may move suturefob (704) into and out of handle (700), as described above in relationto FIG. 4. Suture knob (706) may have one or more visual indicators toindicate how much suture has been removed from suture loop. For example,specific distance markings may be placed on one or more surfaces ofsuture knob (706). Handle (700) may have one or more reference markers(not shown). The distance markings on suture knob (706) may beconfigured such that each distance marking on suture knob (706), whenaligned with the reference marker on handle (700), may correspond to theamount of suture that has been removed from the suture loop. Forexample, before the suture knob has been turned, a distance marking of“0” on suture knob (706) may be aligned with the reference marker, andmay indicate that no suture has been removed from the suture loop. Whenthe suture knob has been rotated a half-rotation, a distance marking of“3” on the suture knob (706) may be aligned with the reference marker onhandle (700), and may indicate that 3 centimeters of suture has beenremoved from the suture loop. The specific distance markings on thesuture knob (706) may depend on how much suture is removed from a sutureloop as the suture knob (706) is rotated.

In other variations, a user may not be able to rotate suture knob (706)beyond a certain point. This feature may prevent a user fromover-tightening the suture loop or unintentionally releasing the sutureloop from the snare loop assembly. In some of these variations, theamount that suture knob (706) is able to rotate may correspond to theamount of excess suture in the suture loop. Generally, by only allowinga user to rotate a suture knob (706) a given distance, a user may knowthat they have removed a predetermined amount of suture from the sutureloop. Depending on the configuration of handle (700), a user knows thatall excess suture has removed from the suture loop, and the suture loopis ready to be released from the snare loop assembly. The suture fob(704) may then be released from the handle, and used to release sutureloop from the snare loop assembly. Suture fob (704) may be released fromhandle (700) in any suitable way. In some variations, one or morebuttons, knobs, or other controls may be actuated to release suture knob(704) from handle (700). By only allowing a user to rotate a suture knob(706) a given amount, the steps of tightening the suture loop andreleasing the suture loop may be divided into two discrete steps, andthus a user does not to release the suture loop immediately afterremoving excess suture therefrom. This gives a user the ability toremove excess suture from the suture loop, and then to release thesuture loop at his or her leisure. This in turn may provide anadditional level of freedom to the user, who may want to attend to othermatters between tightening the suture and releasing it from the snareloop assembly.

In some variations, a suture knob may be disengaged from the handle toact as a suture fob. FIG. 8 depicts one such variation of handle (800)comprising snare control (802) and suture knob (804). Suture knob (804)may have any suitable configuration, as described in U.S. patentapplication Ser. No. 12/055,213. Generally, suture knob (804) may berotated to remove excess suture from a suture loop. In some variations,suture knob may only be rotated a certain amount, as described above.This may correspond to the amount of excess suture that is disposed inthe suture loop. In some variations, one or more visual indicators, suchas those described above, may inform a user how much suture has beenremoved from the suture loop. In some variations, the suture knob (804)may be configured to only require a certain amount of force by a user inorder to rotate suture knob (804). In other variations, the forcerequired to rotate the suture knob (804) may be determined by theresistance provided by the suture loop, and thus may provide a user withtactile feedback while rotating the knob.

Once the suture knob (804) has been rotated to remove excess suture fromthe suture loop, the suture knob may be disengaged from handle (800) toact as a suture fob, as described above. In some variations, suture knob(804) may automatically disengage from handle (800) once suture knob(804) has been rotated a certain amount. In some of these variations,suture knob (804) may comprise threading (not shown) that may engagehandle (800). When suture knob (804) is rotated a certain amount, it maybecome “unscrewed” and release suture knob (804) from handle (800). Inother variations, suture knob (804) may automatically disengage fromhandle (800) when the suture loop is subjected to a predetermined force.In some of these variations, as the suture loop is tightened, it maypull one or more switches, levers, or other controls that disengagessuture knob (804) from handle (800). In still other variations, thehandle (800) may comprise one or more buttons, knobs, or levers that maybe activated to release the suture knob (804) from the handle (800).Additionally, while shown in FIG. 8 to have a square suture knob (804),suture knob (804) may be of any suitable size or shape (e.g., square,rectangle, circle, oval, triangle, etc.).

Also provided here are ergonomically-improved handles. In somevariations, the handle bodies may be shaped to contour to one or moreportions of a user's hand. In other variations, the handles describedhere may have widths greater than their heights. These variations mayhave any suitable height to width rations, including, but not limited toabout 1:1.5, about 1:2, about 1:2.5, about 1:3, or the like. When a userplaces one of these handles down on a surface, he or she may be morelikely to place it on the wider base as opposed to one of the narrowersides. This may be beneficial in preventing device complications, suchas rotation of the snare loop assembly, elongate body, or handle duringa procedure, which may either damage the target tissue or interfere withthe functioning of the closure device. If a user is less likely to placea handle on one of its narrower sides when setting the handle on a trayor another surface, then he or she may be less likely to overly rotatethe handle during a procedure.

In other variations, the handle may comprise one or more protrusionsthat may help ensure the device is laid down with a particularorientation. FIG. 9 shows one such variation of handle (900) comprisingsnare control (902), suture knob (904), suture knob release (906), andprotrusions (908). Protrusions (908) may act to help ensure that handle(900) is only placed with a particular side down. While shown as havingfour separate protrusions (908), handle (900) may have any suitablenumber of protrusions (908), and each protrusion may have any suitablesize and shape.

Tensioning Devices

When the closure devices described above are used to place and tighten asuture loop around a tissue, it may be desirable to manage the tensionapplied to the suture as the suture loop is tightened. Accordingly, theclosure devices described here may comprise one or more tensioningdevices or mechanisms for manage the tension applied to a portion of thesuture loop (e.g., a tail of the suture loop) of the closure device. Insome instances, it may be desirable to limit the maximum tension that isapplied to a suture loop at different times during tightening. Forexample, if a sufficiently large tension is applied to the suture loop,the suture loop may cut through, shear off, or otherwise damage theensnared tissue, and/or may break or damage one or more components ofthe closure device. In some variations, the closure devices describedmay be configured to limit the tension that is applied to a suture loopduring tightening of the suture loop. For example, in variations wherethe suture is attached to a suture fob (such as suture fob (310) shownin FIG. 3A), the suture fob may be configured to break away from asuture upon application of a predetermined force to the suture fob (forexample, between about 8 lbs and about 10 lbs) to limit the tensionapplied to the suture.

In other instances, it may be desirable to facilitate the application ofat least a minimum tension to a suture during tightening of a sutureloop. For example, when the closure devices described here are used toclose the left atrial appendage, it may be desirable to maximize closureof the left atrial appendage, which may reduce the possibility of bloodor other materials passing into or out of the left atrial appendagethrough the ostium of the left atrial appendage. Accordingly tighteningthe suture loop by applying at least a minimum predetermined tension tothe suture may help improve closure of the left atrial appendage, aswill be described in more detail below. In some variations, the closuredevice may comprise one or more tensioning devices that may facilitateapplication of at least a predetermined minimum tension to a sutureduring tightening. Additionally, application of another predeterminedtension to a suture may cause a suture loop to release from the snareloop assembly, as will be described in more detail below. By allowing auser to apply one or more predetermined tensions, the tensioning devicesmay help to reduce user variability between different procedures, whichmay help to improve repeatability of tensioning across multipleprocedures.

In yet other instances, the tensioning devices may be configured tofacilitate the application of at least a minimum predetermined tensionto a suture loop without exceeding a maximum predetermined tension.Additionally or alternatively, a tensioning device may be configured tofacilitate the application of multiple predetermined tensions (or rangesof tensions). For example, in some variations (as will be described inmore detail below), a tensioning device may have a first configurationin which the tensioning device facilitates the application of a firstpredetermined tension to a suture and a second configuration in whichthe tensioning device facilitates the application of a secondpredetermined tension to the suture. It may be desirable to enable auser to apply a first predetermined tension to the suture at a firstpoint in time, and a second predetermined tension to the suture at asecond point in time, as will be described in more detail below.Examples of illustrative tensioning devices will be described in moredetail below.

In some variations, a tensioning device may comprise a force gauge, andmay be used to provide a force measurement or other force indication toa user during tensioning of a suture loop. For example, FIGS. 31A and31B show two variations of tensioning devices that each comprise a forcegauge. FIG. 31A shows a side view of a first variation of tensioningdevice (3100), comprising a handle portion (3102), a suture attachmentmechanism (3104), and a force indicator (3106). Generally, the sutureattachment mechanism (3104) may grip, hold, or otherwise attach to asuture (3108) of a closure device (not shown), as will be described inmore detail below. A user may then pull handle portion (3102) away fromthe closure device to apply a tensile force to the suture (3108). Thesuture attachment mechanism (3104) may be attached to a force gauge (notshown) housed within handle portion (3102), which may measure orotherwise provide an indication of the tension applied to suture (3108)via force indicator (3106).

As mentioned above, suture attachment mechanism (3104) may be anystructure capable of gripping, holding, or otherwise attaching to suture(3108) (e.g., the tail of a suture loop). This connection may betemporary, or permanent. In some variations, the suture attachmentmechanism (3104) may comprise one or more clips, clamps, or othermechanical holding structure for holding suture (3108). In othervariations, the suture (3108) may be wound around one or tied to one ormore portions of the suture attachment mechanism (3104). In variationswhere the suture (3108) is attached to a suture fob (e.g., such assuture fob (3110) shown in FIG. 31A), the suture attachment mechanism(3104) may be configured to grip, hold, or otherwise attach to thesuture fob (3110). For example, in the variation of tensioning device(3100) shown in FIG. 31A, suture attachment mechanism (3104) comprises aprojection (3112) having an aperture (3114) extending at least partiallytherethrough. Aperture (3114) may be sized and shaped such that suturefob (3110) may be placed within aperture (3114) to temporarily engageand hold suture fob (3110) relative to suture attachment mechanism(3104). As a user pulls tensioning device (3100) away from closuredevice, the engagement between the suture fob (3110) and the sutureattachment mechanism (3104) may pull the suture attachment mechanism(3104) away from handle portion (3102), which may apply a force to theforce gauge.

Suture attachment mechanism (3104) may be attached to any suitable forcegauge. For example, in some variations tensioning device (3100) maycomprise a spring force gauge. In other variations, the force gauge maycomprise one or more deflection beams, piezoelectric crystal,force-sensing resistors, combinations thereof, or the like. When a forceis applied to the force gauge, as described immediately above, the forceindicator (3106) may provide a measure or an indication of the tensionbeing applied to suture (3108). The force indicator (3106) may be anymechanism suitable for providing an indication of the tension applied tosuture (3108). For example, in the variation of tensioning device (3100)shown in FIG. 31A, the force indicator (3106) may comprise a moveablemarker (3116) and a scale having indicator marks (3118). As tensioningdevice (3100) applies tension to suture (3108), marker (3116) may beconfigured to move along the scale to give a representation ormeasurement of the tension currently being applied to the suture (3108).Indicator marks (3118) may provide numerical values of the tension beingapplied and/or may provide levels to which a user should pull to achievea desired level of tension. For example, in some variations, the forceindicator (3106) may comprise a first mark and a second mark. In somevariations, the first mark may be located such that in order to releasethe suture loop from the snare loop assembly, a user may pull ontensioning device (3100) until the movable marker (3116) reaches thefirst mark, thereby applying a first predetermined tension. Additionallyor alternatively, the second mark may be located to facilitateapplication of a second predetermined force to the suture duringtightening of the suture loop. Specifically, the user may pull on thetensioning device (3100) until the movable marker (3116) reaches thesecond mark, thereby applying the second predetermined tension. In othervariations, such as shown in FIG. 31B, a tensioning device (3120) maycomprise a force indicator (3122) which comprises a digital display(3124). The remaining elements shown in FIG. 31B are the same as thevariation of tensioning device (3100) shown in FIG. 31A, and are labeledas such. In still other variations, a force indicator may comprise oneor more lights, which may be activated when the tension measured bytensioning device reaches a one predetermined levels, or when thetension supplied falls within a certain range.

FIGS. 32A-32C illustrate another variation of a tensioning device(3200). Specifically, FIGS. 32A-32C show a perspective view and twopartial cross-sectional views, respectively, of tensioning device(3200), comprising a rotation knob (3202) with switch (3203), firstclutch (3204), second clutch (3206), spooling member (3208), and base(3210). Base (3210) of tensioning device (3200) may be attached to orotherwise be formed as a part of a handle (not shown) of a closuredevice (not shown), such as one or more of the closure devices describedin more detail above, and an end of suture (3212) may be attached to onemore portions of spooling member (3208). Rotation knob (3202) may berotated to rotate spooling member (3208) relative to base (3210), whichmay cause suture (3212) to wrap around spooling member (3208). As shownin FIGS. 32A-32C, spooling member (3208) may comprise a recessed portion(3214) in which the suture (3212) is wrapped. Tensioning device (3200)may be moved between a first configuration, in which tensioning device(3200) is configured to facilitate the application of a firstpredetermined tension to suture (3212), and a second configuration, inwhich the tensioning device (3200) is configured to facilitate theapplication a second predetermined tension to suture (3212).Additionally, tension device (3200) may limit the maximum tensionapplied to suture (3212), as will be described in more detail below.

As shown in FIGS. 32B and 32C, base (3210) may comprise a shaft (3216).Second clutch (3206) may be rotatably attached to shaft (3216), suchthat second clutch (3206) may freely rotate around shaft (3216). In somevariations, the connection between the second clutch (3206) and shaft(3216) may also be configured such that the second clutch (3206) doesnot move axially relative to the shaft (3213), but need not be. Each offirst (3204) and second (3206) clutches frictionally engages spoolingmember (3208) via clutch plates (3218), such that rotation of the first(3204) and/or second (3206) clutches may rotate the spooling member(3208), and vice versa.

In some variations, switch (3203) of rotation knob (3202) may beattached to an engagement rod (3220). Engagement rod (3220) may beconfigured to rotate relative to base (3210) as rotation knob (3202) isrotated. Switch (3203) may be moved between a first position, as shownin FIG. 32B, and a second position, as shown in FIG. 32C, to movetensioning device (3200) between a first configuration and a secondconfiguration. Moving switch (3203) from the first position to thesecond position may advance engagement rod (3220) into engagement withthe second clutch (3206). Specifically, one or more grooves (3222) onthe engagement rod (3220) may engage with one or more projections (3224)of the second clutch (3206) such that rotation of the engagement rod(3220) is translated to the second clutch (3206), as will be describedin more detail below. Moving the switch (3203) back to the firstposition may disengage the engagement rod (3220) and the second clutch(3206), which may allow the engagement rod (3220) to rotate relative tothe second clutch (3206).

As shown in FIGS. 32A-32C, rotation knob (3202) is directly attached tofirst clutch (3204), such that rotation of rotation knob (3202) relativeto base (3210) also rotates the first clutch relative to base (3210).When tensioning device (3200) is in a first configuration (e.g., switch(3203) is in the position shown in FIG. 32B and engagement rod (3220) isdisengaged from the second clutch (3206)), rotation of the rotation knob(3202) and first clutch (3210) relative to base (3210) may also rotatespooling member (3208) by virtue of the frictional engagement betweenthe clutch plates (3218) of the first clutch (3210) and the spoolingmember (3208). As spooling member (3208) is rotated, suture (3212) maybe wrapped around spooling member (3208). Additionally, the frictionalengagement between spooling member (3208) and the second clutch (3206)may cause the second clutch (3206) to rotate around shaft (3216). As thesuture (3212) is wrapped around the spooling member (3208), thetensioning device (3200) may increase the tension applied to suture(3212), which may act to resist rotation of the spooling member (3208).Eventually, this rotational resistance may overcome the frictionalforces between the first clutch (3204) and the spooling member (3208),causing the clutch plates (3218) of the first clutch (3204) to sliprelative to spooling member (3208). The first clutch (3204) may beconfigured such that clutch plates (3218) of first clutch (3204) beginslipping when a first predetermined tension (e.g., about 6 pounds) isapplied to suture (3212). Additionally, because rotation of the rotationknob (3202) may no longer wrap suture (3212) around spooling member(3208) (due to the slipping between first clutch (3204) and spoolingmember (3208)), the tensioning device (3200) may be prevented fromincreasing the tension beyond the first predetermined tension while thetensioning device (3200) is in the first configuration.

When tensioning device (3200) is in its second configuration, as shownin FIG. 32C, engagement rod (3220) may engage second clutch (3206) suchthat rotation of rotation knob (3202) rotates both first (3204) andsecond (3206) clutches relative to base (3210). As rotation knob (3202)is rotated, the frictional engagement between the spooling member (3208)and clutch plates (3218) of first (3204) and second (3206) clutches maycause the spooling member (3208) to rotate. This rotation may windsuture (3212) around spooling member (3208) until the tension in suture(3212) overcomes the frictional forces provided by both the first (3204)and second (3206) clutches, at which point the clutch plates (3218) mayslip relative to spooling member (3208). The tensioning device (3200)may be configured such that slipping between the first (3204) and second(3206) clutches and spooling member (3208) occurs at a secondpredetermined suture tension (e.g., about 10 pounds) when the device isin the second configuration. Further rotation of rotation knob (3202)may not increase tension in the suture (3212) (due to slipping betweenthe first (3204) and second (3206) clutches and the spooling member(3208)), which may prevent the tensioning device (3200) from increasingthe tension beyond the second predetermined tension while the tensioningdevice (3200) is in the second configuration.

The tensioning device (3200) may be moved between first and secondconfigurations to selectively manage the tension applied to suture(3212). For example, in some variations, a user may place the tensioningdevice (3200) in a first configuration, and may rotate the rotation knob(3202) until the tension in suture (3212) reaches a first predeterminedtension (e.g., about 6 pounds), causing the rotation knob (3202) andfirst clutch (3204) to begin slipping relative to spooling member(3208), which may prevent additional tensioning. Once this tension hasbeen achieved, the tensioning device (3200) may be moved to the secondconfiguration, and the rotation knob (3202) may again rotated untilsuture (3212) reaches a second predetermined tension (e.g., about 10pounds), again causing rotation knob (3202) (and first (3204) and second(3206) clutches) to begin slipping relative to spooling member, whichmay prevent additional tensioning.

FIGS. 33A-33G illustrate yet another variation of a tensioning device(3300) that may be used to tighten a suture loop. Specifically, FIGS.33A and 33B show a perspective view and cross-sectional side view,respectively, of tensioning device (3300). As shown there, tensioningdevice (3300) may comprise a housing (3302) having handle portion (3304)and track (3306), first extension member (3308), second extension member(3310), first constant force spring (3312), second constant force spring(3314), and suture attachment mechanism (3316). Generally, each of thefirst (3308) and second (3310) extension members may be at leastpartially held within housing (3302), and may slide relative to housing(3302), as will be described in more detail below. First extensionmember (3308), second extension member (3310) and/or housing (3302) mayadditionally comprise one or more stops (not shown) or other featuresthat may prevent first extension member (3308) and/or second extensionmember (3310) from disengaging from the housing (3302) as they slideoutward from housing (3302).

First (3312) and second (3314) constant force springs each may comprisea rolled ribbon of a material (e.g., stainless steel) which may exert apredetermined force when the ribbon as the ribbon is uncoiled andcoiled. Specifically, first constant force spring (3312) may beconfigured to provide a first predetermined force (x1) (e.g., about 3pounds, about 4 pounds, about 5 pounds, about 6 pounds, about 7 pounds,or the like) as the first constant force spring (3312) is coiled and/oruncoiled, and second constant force spring (3314) may provide a secondpredetermined force (x2) (e.g., about 3 pounds, about 4 pounds, about 5pounds, about 6 pounds, about 7 pounds, or the like) as the secondconstant force spring (3314) is coiled and/or uncoiled. The force (x1)provided by the first constant force spring (3312) may be the same as,or may be different from, the force (x2) provided by the second constantforce spring (3314). For example, in some variations, the first constantforce spring (3312) may be configured to provide a force (x1) of about 6pounds, while the second constant force spring (3314) may be configuredto provide a force (x2) of about 4 pounds. A first end of the firstconstant force spring (3312) may be attached to the first extensionmember (3308), while a second end of the first constant force spring(3312) may be attached to the housing (3302) (e.g., via a first anchorpost (3318), or the like). Similarly, a first end of the second constantforce spring (3314) may be attached to the second extension member(3310), while a second end of the second constant force spring (3314)may be attached to the housing (3302) (e.g., via a second anchor post(3320), or the like). As shown in FIGS. 33A-33G, suture attachmentmechanism (3316) may be attached to, or otherwise extend from, firstextension member (3308), but it should be appreciated that in somevariations the suture attachment mechanism may be attached to the secondextension member. In still other variations, each of suture first andsecond extension members may comprise a suture attachment mechanism.

Tensioning device (3300) may facilitate tightening of a suture loop (notshown). In use, tensioning device (3300) may grip, hold, or otherwiseattach to a suture (3322) via suture attachment mechanism (3316). Sutureattachment mechanism (3316) may be any structure capable of gripping,holding, or otherwise attaching to a suture (or to a suture fob, invariations where a portion of the suture is attached to a suture fob),such as one or more of the suture attachment mechanisms described inmore detail above. For example, in the variation of tensioning device(3300) shown in FIGS. 33A-33G, suture attachment mechanism (3316)comprises a projection (3324) with an aperture (3326) for receiving andholding suture fob (3328).

Once suture attachment mechanism (3316) has engaged suture (3322) (e.g.,via a suture fob), the tensioning device (3300) may be configured toapply either a first predetermined tension or a second predeterminedtension to suture (3322). To apply the first predetermined tension, thetensioning device (3300) may be placed in a first configuration, asshown in FIG. 33A, and a user may grip housing (3302) (e.g., via handleportion (3304)) and pull tensioning device (3300) away from the closuredevice (not shown) to apply tension to suture (3322). This tension mayalso act to pull first extension member (3308) away from housing (3302).First constant force spring (3312), by virtue of its attachment to firstextension member (3308), may resist this movement of first extensionmember (3308) until the tension is approximately equal to thepredetermined force (x1) provided by the first constant force spring(3312). When the tension in suture (3322) reaches this force (x1), firstconstant force spring (3312) may begin to uncoil, and first extensionmember (3308) may slide at least partially out from housing (3302), asshown in a perspective view and a cross-sectional side view in FIGS. 33Cand 33D, respectively. Accordingly, to allow tensioning device (3300) toapply the first predetermined tension (which may be approximately thesame as force (x1) provided by first constant force spring (3312)), auser may pull tensioning device (3300) until the first extension member(3308) begins to slide out of housing (3302). For example, in variationswhere first constant force spring (3312) is configured to supply a forceof about 6 lbs, the tension applied by tensioning device (3300) duringmovement of the first extension member (3308) may be about 6 lbs.Additionally, because first constant force spring (3312) continues toapply the predetermined force (x1) as first extension member (3308)moves relative to housing (3302), the tensioning device (3300) maymaintain the first predetermined tension in suture (3322) and in someinstances may prevent the user from exceeding the predetermined tension.

To configure the tensioning device (3300) to apply a second pre-settension to suture (3322), first extension member (3308) and secondextension member (3310) may temporarily be connected to place thetensioning device (3308) in a second configuration. For example, asshown in FIG. 33E, a pin (3338) or other locking structure may beinserted through track (3306) of housing (3302) and may be placed atleast partially through an aperture (3330) of second extension member(3310) and aperture (3332) of first extension member (3308) such thatpin (3338) couples first (3308) and second (3310) extension members tohold the extension members relative to each other. To apply the secondpredetermined tension, a user may grip housing (3302) (e.g., via handleportion (3304)) and pull tensioning device (3300) away from the closuredevice (not shown) to apply tension to suture (3322). This tension mayalso act to pull first (3308) and second (3310) extension members awayfrom housing (3302) (because pin (3338) couples the first (3308) andsecond (3310) extension members, the extension members may move togetheras a single unit). In this instance, both first constant force spring(3312) (by virtue of its attachment to first extension member (3308))and second constant force spring (by virtue of its attachment to secondextension member (3310)), may resist this movement of first (3308) andsecond (3310) extension members until the tension in suture (3322)reaches the sum of the forces (x1) and (x2) provided by first (3312) andsecond (3314) constant force springs. When the tension in suture (3322)reaches this force ((x1)+(x2)), first (3312) and second (3314) constantforce springs may begin to uncoil, and first (3308) and second (3310)extension members may slide at least partially out from housing (3302),as shown in a perspective view and a cross-sectional side view in FIGS.33F and 33G, respectively. As first (3308) and second (3310) extensionmembers slide from housing (3302), pin (3338) may slide within track(3306). Accordingly, to allow tensioning device (3300) to apply thefirst predetermined tension (which may be approximately equal to the sumof forces (x1) and (x2) provided by first (3312) and second (3314)constant force springs), a user may pull tensioning device (3300) untilthe first (3308) and second (3310) extension members start being pulledout of housing (3302). For example, in variations where first constantforce spring (3312) is configured to supply a force of about 6 lbs andthe second constant force spring (3314) is configured to supply a forceof about 4 lbs, the tension applied by tensioning device (3300) duringmovement of the first (3308) and second (3310) extension member may beabout 10 lbs. Additionally, because first (3312) and second (3314)constant force springs continue to apply the first and secondpredetermined forces ((x1) and (x2)) as first (3308) and second (3310)extension members move relative to housing (3302), the tensioning device(3300) may maintain the first predetermined tension in suture (3322) andin some instances may prevent the user from exceeding the predeterminedtension.

While each of the extension members are shown in FIGS. 33A-33G as beingconnected to a single constant force spring, it should be appreciatedthat each of the extension members may be connected to any suitablenumber of constant force springs (e.g., one, two, or three or moreconstant force springs). Additionally, while shown in FIGS. 33A-33G ashaving two extension members, it should be appreciated that tensioningdevice (3300) may comprise any suitable number of extension members(e.g., one, two, or three or more). For example, in some variations, atensioning device may comprise a single extension member. In some ofthese variations, the extension member may be configured to extend fromthe housing when a predetermined tension is applied to a suture. Inothers of these variations, the extension member may be selectivelyconnected to multiple constant force springs such that the tensioningdevice may supply one of a plurality of predetermined tensions to asuture. For example, the extension member may be configured to switchfrom attachment to a first constant force spring (or a first pluralityof constant force springs), which may allow the tensioning device toapply a first predetermined tension (e.g., about 6 pounds) to thesuture, to attachment to a second constant force spring (or secondplurality of second constant force springs) to allow the tensioningdevice to apply a second predetermined tension (e.g., about 10 pounds)to the suture.

FIGS. 35A-35D depict a variation of a closure device (3500) comprising atensioning mechanism (3502). As shown in a perspective view FIG. 35A,the closure device (3500) may comprise a handle (3504), an elongate body(3506), and a snare loop assembly (3508). The closure device handle(3504), elongate body (3506), and snare loop assembly (3508) may includeany combination of handles, elongate bodies, and snare loop assembliesor features thereof, as described above. In some variations, the snareloop assembly (3508) may comprise a snare and a suture loop releasablyconnected via a retention member, and the snare may be used to open andclose the snare loop assembly (3508) via a snare control (3510), asdescribed in more detail above. The snare control (3510) may be anyknob, slider, lever, button, or the like.

The handle (3504) of the closure device (3500) may comprise a tensioningmechanism (3502). As shown in FIG. 35A and in an exploded view in FIG.35B (with a bottom portion of the handle (3504) removed), the tensioningmechanism (3502) may comprise a rotation knob (3512), an axle (3514)attached to an indicator body (3516), and a spring member (3518)connecting the rotation knob (3512) and the axle (3514). Axle (3514) maybe rotatably connected to the handle (3504) such that rotation of theaxle (3514) in a first direction (as indicated by arrow (3546)) appliestension to a suture (3520). For example, the tensioning mechanism (3502)may comprise a spool (3522) which may be rotated as the axle (3514) isrotated. The axle (3514) may rotate the spool (3522) in any suitablemanner. In some variations the axle (3514) may be fixedly attached tothe spool (3522) such that the axle (3514) and spool (3522) rotatetogether. In other variations (such as the variation shown in FIGS.35A-35D), the axle (3514) may be connected to a first miter gear (3524)and the spool (3522) may be connected to a second miter gear (3526)which engages the first miter gear (3524). Rotation of the axle (3514)may rotate the first miter gear (3524), which may rotate the secondmiter gear (3526) and the spool (3522). Rotation of the spool (3522) ina first direction may collect suture (3520) onto the spool, which maytension the suture (3520) and tighten a suture loop (not shown) of thesnare loop assembly (3508). Rotation of the spool (3522) in a seconddirection may release suture (3520) from the spool (3522), and mayreduce tension on the suture (3520). The rotation knob (3512) may beused to rotate the axle (3514) and apply tension to the suture (3520),as will be described in more detail below. The connection between theaxle (3514) and the indicator body (3516) may be such that the axle(3514) and indicator body (3516) may rotate together. In somevariations, the axle (3514) and indicator body (3516) may be formed asmultiple components and joined together, or may be formed as a singlecomponent.

In some variations, the axle (3514) may be configured to rotate in onlyone direction relative to the handle (3504). For example, in somevariations, the axle (3514) may comprise a ratchet mechanism (3528) andthe handle (3504) may comprise a pawl (3530), such that pawl (3530)allows rotation of the ratchet mechanism (3528) (and thus the axle(3514)) in a first direction, but prevents rotation of the ratchetmechanism (3528) in the opposite direction. In some of these variations,the pawl (3530) may be moveable or otherwise disengaged from the ratchetmechanism (3528) to allow rotation of the ratchet mechanism (3528) ineither direction. For example, in the variation shown in FIGS. 35A-35D,the handle (3504) may comprise a button (3532) which may temporarilydisengage the pawl (3530) from the ratchet mechanism (3528), therebyallowing rotation of the axle (3514) in a second direction. The pawl(3530) may be disengaged by any suitable mechanism (e.g., a button, aslider, a lever, or the like), and may be disengaged when it isdesirable to release tension that has been applied to the suture (3520).

When the snare loop assembly (3508) comprises a suture loop releasablyattached to one or more components of the snare loop assembly (3508)(e.g., a snare), the tensioning mechanism (3502) may be configured torelease the suture loop and to tighten the suture around tissue capturedby the snare loop assembly (3508). Specifically, when the snare loopassembly (3508) captures and is closed around a target tissue, therotation knob (3512) may be rotated to tighten the suture loop (e.g., toreduce the diameter of the suture loop). Rotation of the rotation knob(3512) may be at least partially translated to the axle (3514) and theindicator body (3516) via the spring member (3518). For example, thespring member (3518) may comprise a torsional spring (3534) with a firstleg (3536) attached to the rotation knob (3512) and a second leg (3538)attached to the axle (3514) and/or the indicator body (3516). Rotationof the rotation knob (3512) may apply a force to the first leg (3536),and this force may be translated to the second leg (3538) which mayresult in rotation of the axle (3514) and indicator body (3516). Invariations where the suture loop comprises excess suture (e.g., withinthe elongate body (3506)), rotation of the rotation knob (3512) maycause this excess suture to be removed from the suture loop (e.g.,through a suture knot). In some of these variations, the spring force ofthe spring member (3518) may be stiff enough such that the spring member(3518) does not twist during this initial tightening (i.e., before thesuture loop is released from the snare loop assembly), and thus therotation knob (3512) does not rotate relative to the axle (3514) andindicator body (3516). The rotation knob (3512) can be used to rotatethe axle (3514) and indicator (3516), as shown in FIG. 35C, which may inturn rotate the spool (3522) to tighten the suture loop until the sutureloop is released from the snare loop assembly (e.g., the suture loop ispulled through a portion of a retention member).

After the suture loop has been released from the snare loop assembly,continued rotation of the rotation knob (3512) may further tighten thesuture around the captured tissue. As the suture loop is tightenedaround tissue, rotation of the rotation knob (3512) increases thetension on the suture (3520). This increased tension may resist furtherrotation of the axle (3514) and indicator body (3516). Eventually, theincreased tension may overcome the spring force of the spring member,the spring member (3518) will begin to twist such that the first leg(3536) may rotate toward the second leg (3538) and the rotation knob(3512) rotates relative to the indicator body (3516). The indicator body(3516) may comprise a first set of markings (3540) and the rotationhandle (3512) may comprise a second set of markings (3542), such thatthe relative positioning between markings (3540) on the indicator body(3516) and the markings (3542) on the rotation handle (3512) isindicative of the force being applied to the suture (3520). For example,in some variations, one or more of the markings may provide numericalvalues of the tension being applied to the suture and/or may providelevels to which a user should pull to achieve a desired level oftension. In some variations, the rotation knob (3512) may be rotateduntil the relative positioning between the markings (3540) and (3542)indicates that a desired final tightening force has been applied to thesuture (3520). When the force applied to the suture (3520) is at orbelow a first predetermined level (e.g., less than or equal to about 6lbs, less than or equal to about 5 lbs, or the like), the markings onthe rotation handle and the indicator body may be aligned in a firstconfiguration (for example, in the variation of the closure device(3500) described above in relation to FIGS. 35A-35D, the markings (3542)of the rotation handle (3512) may be aligned with the thinnest portionof the ramped markings of the indicator body (3516) as depicted in FIG.35C). When the force applied to the suture (3520) reaches a secondpredetermined level (e.g., about 9 lbs, about 10 lbs, or the like), themarkings may be aligned in a second configuration (for example, in thevariation of the closure device (3500) described above in relation toFIGS. 35A-35D, the markings (3542) of the rotation handle (3512) may bealigned with the thickest portion of the ramped markings of theindicator body (3516) as depicted in FIG. 35D). It should be appreciatedthat the markings of the indicator body and the rotation handle may bealigned in any number of different configurations to representrespective force levels applied to the suture (3520) by the tensioningmechanism (3502).

In some variations, the handle (3504) may further comprise a stop (3544)which may resist or otherwise prevent unintentional rotation of theindicator body (3516) and axle (3514). The stop (3544) may be include afirst position in which the stop (3544) engages the indicator body(3516) and/or axle (3514) to prevent these elements from rotatingrelative to handle (3504). When a user wishes to tighten the sutureloop, the stop (3544) may be moved to a second position in which thestop (3544) does not engage the indicator body (3516)/axle (3514),thereby allowing rotation of the tensioning mechanism (3502).Additionally, while the closure mechanism (3502) described above withrespect to FIGS. 35A-35D is shown as being integrated with the handle(3504), it should be appreciated that the closure mechanism may be aseparate device from the closure device (3500) and may engage andtighten a suture loop of the closure device (3500).

Methods

Methods for closing the left atrial appendage are also described here.It should be appreciated that any of the devices described above may beused in conjunction with one or more of the methods described here orthose described in U.S. patent application Ser. No. 12/055,213.Generally, methods described here comprise accessing the left atrialappendage. Once access has been achieved, a closure device (such asthose described above) may be advanced to the left atrial appendage. Insome variations, the closure devices may be advanced and positioned withthe help of one or more guide devices and/or one or morestabilizing/positioning devices (e.g., an expandable member or thelike). The closure device may be used to ensnare and close the leftatrial appendage. A suture loop or other closure element may betightened and released from the closure device to hold the left atrialappendage in closed configuration. Once or more tensioning devices maybe utilized to tighten and/or release the suture loop. The closuredevice may be withdrawn, and a portion of the suture may be severed.These steps will be described in more detail below.

As mentioned above, some variations of the methods described here maycomprise gaining access to the left atrial appendage. In somevariations, the methods for closing the left atrial appendage includeaccessing the left atrial appendage from both the inside of the heartand the outside of the heart. To access the inside of the heart, thevasculature is typically used. For example, access may be obtained viaone or several of the various veins or arteries (jugular, femoral,carotid, etc.). In some variations, the heart is accessed on the insidevia the common femoral vein (e.g., the left common femoral vein) using astandard Seldinger technique with a needle. An introducer wire may thenbe advanced through the needle, followed by an introducer sheath. Theintroducer wire may then be removed. In some variations, a guidingcatheter sheath may be placed as an alternative to an introducer sheathor the initial sheath may be replaced with a guiding catheter sheath.

Using fluoroscopy, an angiogram performed through the sheath, a catheterplaced through the sheath, a guiding catheter sheath, or any combinationthereof, may be performed to observe anatomical characteristics andconsiderations of the access route for the purpose of transeptal accessinto the left atrium (e.g., tortuosity, clots, devices, such as venacava filters, etc.). Fluoroscopy, ultrasound, intracardiacechocardiography, extracardiac echocardiography, transesophagealechocardiography, or combinations thereof, may be used to help visualizetranseptal access to the left atrium, and access to the left atrium maybe obtained using standard transeptal access techniques.

For access to the heart from the outside, a subthoracic access point maybe used. The access point is typically identified based on patientanatomical characteristics. In some variations, the access point may beany suitable location (e.g., intercostal access via a sternotomy,thoracostomy, or thoracotomy, right of the xiphoid process and pointedtowards the patient's left shoulder, or in the costal cartilage orxiphoid process itself). Once the access point has been determined, aneedle (e.g., a 17G Tuohy needle) may be advanced using standardpericardiocentsesis techniques under fluoroscopic guidance. After accessto the pericardium has been obtained, a guidewire may be advancedthrough the needle under fluoroscopic visualization within thepericardiac sac. The needle may then be removed. Access to thepericardial space has thus been obtained.

In other variations, the left atrial appendage may be closed off usingthe systems and devices described here without performing both accessprocedures as described above. For example, in some variations themethods comprise advancing a first guide having a proximal end and adistal end into the left atrial appendage, through the left atrialappendage, and out of the left atrial appendage, such that one of theproximal or distal ends is within the vasculature, and one of theproximal or distal ends is within the subthoracic space.

By virtue of gaining access to the left atrial appendage, one or moreguides having alignment members may be advanced to the left atrialappendage. These guides may be any suitable guide, such as thosedescribed in U.S. patent application Ser. No. 12/055,213. For example,first and second guides having alignment members may be used to guidethe procedure. The alignment member may be any suitable alignment member(e.g., interconnecting elements, one or more vacuum members, radiopaqueor echogenic markers, members that are configured to produce an audibleresponse, magnets, etc.). In some variations, the alignment members aremagnets located at the distal ends of the guides. The magnets may bemade from or comprise any suitable magnetic material, e.g., a rare earthmagnet, such as neodymium-iron-boron, cobalt-samarium, or other powerfulfixed magnet elements. These guides may be used for guiding additionaltools and/or devices to the left atrial appendage.

For example, in some variations, a first guide may be advanced into theleft atrial appendage, while the second guide may be advanced into thepericardial space adjacent to the left atrial appendage. Either of theseguides may be advanced under any of a variety of visualizationtechniques, e.g., fluoroscopic visualization, ultrasound visualization,some combination thereof, etc. Once the first and second guide membershave been advanced to the left atrial appendage, one or more positioningand/or stabilizing elements (e.g., balloons or other expandablestructures) may be advanced over or in conjunction with the first guide(e.g., it may be coupled to or be part of the first guide) and into theleft atrial appendage. Similarly, a closure device may be advanced overthe second guide to the exterior of the left atrial appendage. It shouldbe appreciated that the closure device may be any of the closure devicesdescribed above.

When placed in the left atrial appendage, the positioning element may beused to help position the snare loop assembly of a closure device. Insome variations, an expandable structure may be inflated or otherwiseexpanded in or near the opening of the left atrial appendage and thesnare loop assembly of the closure device may be closed around the leftatrial appendage distally of the expandable structure. In thesevariations, the expandable structure may help position the closuredevice away from the Coumadin ridge. In other variations, the expandablemember may be expanded inside of the left atrial appendage. In some ofthese variations, when the expandable member is expanded, the leftatrial appendage may become distended and its shape changed from roughlyconical to roughly spherical, thus better defining the junction betweenthe left atrial appendage and left atrium. In addition, the expandablemember in its expanded state may be at a pressure much greater than thatof the left atrium proper, resulting in a significant differential intension between the left atrial appendage and the left atrium. In thesevariations, the expandable member may help position the closure devicenear the base of the left atrial appendage. In still other variations,one expandable structure may be expanded in or near the opening of theleft atrial appendage while a second expandable structure may beexpanded inside of the left atrial appendage. In these variations, thesnare loop assembly of the closure device may be closed around the leftatrial appendage between the two expandable structures, which may helpensure correct device positioning.

It should be appreciated that the expandable structure may be anysuitable expandable structure. In some variations, one or more theexpandable structures may be a balloon or another inflatable structure.In some of these variations, the balloon or balloons may be attached toa catheter. In some variations, the balloon or inflatable structure maybe configured to be detached in an expanded state inside of the leftatrial appendage. In other variations, the expandable structure maycomprise an expandable mesh or cage structure. This mesh may beself-expanding or mechanically expandable, and may be made from anysuitable material (e.g., platinum, nitinol, stainless steel, Dacronwool, PTFE, combinations thereof, or the like). Again, the expandablemesh or cage structure may be configured to be detached in an expandedstate in the left atrial appendage, but need not be.

While the expandable member is in an expanded state, the snare loopassembly may be moved to an open configuration and may be placed arounda portion of the left atrial appendage. Once placed around the leftatrial appendage, the snare loop assembly may be closed around the leftatrial appendage. In some variations, the snare loop assembly is placedaround the left atrial appendage while the balloon is in its deflated orunexpanded stated, and then the balloon is expanded after the snare loopassembly is closed. In some instances it may be desirable to confirmproper closure of the appendage prior to tightening of the suture. Ifclosure is not adequate or otherwise not desirable, the snare loopassembly may be opened, repositioned, closed, and then confirmed onceagain.

Once proper closure has been affected, the suture loop may be tightenedto release the suture loop from the snare loop assembly. In somevariations, the snare loop assembly may then be returned to an openconfiguration and the suture loop may be tightened again. This may actto help ensure that the suture loop is sufficiently tightened around theleft atrial appendage. In some variations, a user may re-tighten thesuture loop after waiting for a period of time. This waiting period mayallow tissue to readjust and settle within suture loop, which may allowfor a tighter closure of tissue. This period of time may be any suitableperiod of time, such as, for example, greater than about 30 seconds,greater than about a minute, or greater than about 2 minutes. Afterreleasing the suture loop from the snare loop assembly, the closuredevice may be withdrawn. In some variations, it may be desirable tofurther tighten the suture loop after the closure device has beenwithdrawn. This may be accomplished with one or more additional devices(e.g., a knot pusher).

It should be appreciated that one or more of the tensioning devicesdescribed above may be utilized to manage the tension applied to thesuture loop during tightening of the suture loop, which may increaserepeatability of suture loop tightening by reducing user variation. Forexample, FIG. 34 depicts a flowchart of one method by which one or moretensioning device may be used to assist in the tightening of a sutureloop to close off the left atrial appendage. While described here asbeing used to close the left atrial appendage, it should be appreciatedthat the methods described here may be used to close any suitable targettissue. As mentioned above, a snare loop assembly may be advanced andpositioned around the left atrial appendage (3400), such as in one ofthe manners described in more detail above. Once placed around the leftatrial appendage, the snare loop assembly may be closed around the leftatrial appendage to close the left atrial appendage (3402). Once properpositioning of the closed snare loop assembly has been achieved (andoptionally confirmed via visualization), a tensioning device may be usedto release the suture loop from the suture loop assembly. Specifically,a tensioning device may be used to apply a first predetermined tensionto the suture loop (3406). The tensioning device and closure device maybe configured such that suture loop may be released from the snare loopassembly at or before the time the tension applied to the suture reachesthe first predetermined tension. The first predetermined tension may beany suitable value. In some instances, variations resulting frommanufacturing and/or delivery conditions may affect the tension requiredto release the suture loop from the snare loop assembly. In theseinstances, it may be desirable to set the first predetermined tension toa value greater than or equal to the largest release tension expected ofthe closure device. For example, the suture loop may be configured torelease from the snare loop assembly at tensions less than or equal toabout 6 pounds (e.g., between about 5 pounds and about 6 pounds, etc.).In some of these variations, the tensioning device may be configured toapply a first predetermined tension of about 6 pounds or a firstpredetermined tension greater than about 6 pounds, which may allow thesuture loop to be released when the first predetermined tension has beenapplied to the suture.

Once the suture loop has been released from the snare loop assembly, theremaining components of the snare loop assembly (e.g., a snare and/orretention member) may optionally be re-opened (3408), as mentionedimmediately above, and the suture loop may be tightened around the leftatrial appendage. In some variations, a tensioning device may provide asecond predetermined tension to the suture loop (3410) to tighten thesuture loop. Applying a second predetermined tension to the suture loopmay help to improve the closure of the left atrial appendage, which mayreduce the likelihood that blood or other materials (e.g., thrombi) areable to pass through the ostium of the left atrial appendage.Specifically, in some instances it may be desirable to tighten thesuture loop to achieve a certain diameter (or range of diameters) of thesuture loop as it closes around the left atrial appendage. Additionallyor alternatively, it may be desirable to tighten the suture loop suchthat the suture loop provides a certain tightening force to the ensnaredtissue (e.g., at least about 4 lbs, at least about 5 lbs, between about3 pounds and about 6 pounds, etc.). The second predetermined tension maybe configured such that application of the second predetermined tension(e.g., about 10 pounds, at least about 10 pounds, between about 9pounds, between about 11 pounds, or the like) to the suture may achievea desired diameter of the suture loop and/or provides a desiredtightening force to the ensnared tissue. This, in turn, may increase thelikelihood that the left atrial appendage is sufficiently closed.Additionally, repeated application of the predetermined tension acrossmultiple procedures may allow for predictable and repeatable closure ofthe left atrial appendage. The tensioning device may also be configuredto limit the user's ability to exceed the second predetermined tension,or to exceed an undesirable tension level.

The closure device may optionally be left in place for a specific amountof time (e.g., greater than about 30 seconds, greater than about aminute, greater than about 2 minutes, greater than about 4 minutes, orthe like), to allow the ensnared tissue to reposition or otherwisesettle within the suture loop, if at all (3412). The suture loop maythen be re-tightened (3414). In some variations, a tensioning device mayapply a third predetermined tension to the suture loop. It should beappreciated that in some variations, the third predetermined tension maybe approximately equal to the second predetermined tension. In othervariations, the third predetermined tension may be greater than thesecond predetermined tension. In still other variations, the thirdpredetermined tension may be less than the second predetermined tension.Optionally, the steps of leaving the closure device in place for aperiod of time and then re-tightening the suture loop may be repeatedone or more times as necessary.

While tensioning devices are described above as applying a firstpredetermined tension (to release suture loop from snare loop assembly),a second predetermined tension (to tighten the suture loop) and a thirdpredetermined tension (to re-tighten the suture loop), it should beappreciated that tensioning devices may only be used during some of theabove-mentioned steps. Additionally, in some variations, the sametensioning device is used to provide multiple different predeterminedtensions to the suture loop (e.g., a tension device may be used toprovide a first predetermined tension at a first point in time, and thenmay be used to provide a second predetermined tension at a second pointin time). In other variations, different tensioning devices may be usedto provide different predetermined tensions (e.g., a first tensioningdevice may be used to provide a first predetermined tension (e.g., about6 pounds), while a second tensioning device may be used to provide asecond predetermined tension (e.g., about 10 pounds).

It should be appreciated that any of the tensioning devices describedabove may be used to apply the first and/or second (and/or third, ifapplicable) predetermined tensions to the suture loop during tighteningof the suture loop. For example, in some variations a tensioning devicecomprising a force gauge (e.g., tensioning device (3100) described abovewith respect to FIG. 31A) may be used to ensure that one or morepredetermined tensions are applied to the suture loop. In thesevariations, a user may attach the tensioning device to the suture usinga suture attachment mechanism (as described in more detail below), andmay apply tension to the suture using the tensioning device. Forexample, to release the suture loop from the snare loop assembly, theuser may apply increasing tension until the force indicator of thetensioning device indicates that the first predetermined tension hasbeen applied. Additionally or alternatively, when tightening (orre-tightening) the suture loop, the user may apply increasing tensionuntil the force indicator indicates that the second (or third)predetermined tension has been applied.

In other instances, the variation of the tensioning device (3200)described above in relation to FIGS. 32A-32C may also be used to applyone or more predetermined tension values to the suture loop. Forexample, tensioning device (3200) may be configured to apply the firstpredetermined tension when placed in the first configuration (as shownin FIG. 32A), and to apply the second predetermined tension when placedin the second configuration (as shown in FIG. 32B). To release sutureloop from the snare loop assembly, the tensioning device (3200) may beattached to the suture and placed in the first configuration, androtating knob (3202) may be rotated until the first predeterminedtension is reached and the first clutch plate (3204) begins slippingrelative to spooling member (3208). Similarly, to tighten (orre-tighten) the suture loop, the tensioning device (3200) may be placedin the second configuration, and rotating knob (3202) may again berotated until the second predetermined tension is reached and the clutchplates (3218) of the first (3204) and second (3206) clutches beginslipping relative to spooling member (3208). Additionally, in thesevariations the tensioning device (3200) may limit the tension applied bythe tensioning device (e.g., due to the slipping of clutch plates),which may help prevent premature tightening and/or over-tightening ofthe suture loop.

In other variations, the variation of tensioning device (3300) describedabove in relation to FIGS. 33A-33G may also be used to apply one or morepredetermined tension values to the suture loop. In some of thesevariations, tensioning device (3300) may be configured to apply thefirst predetermined tension when in the first configuration (asdescribed above in relation to FIGS. 33A-33D) and may be configured toapply the second predetermined tension when in the second configuration(as described above in relation to FIGS. 33E-33G). Accordingly, torelease the suture loop from the snare loop assembly, the tensioningdevice (3300) may be attached to the suture and placed in the firstconfiguration, and tensioning device (3300) may be pulled away from theclosure device (not shown) until the tension applied to the suturereaches the first predetermined tension, and the first extension member(3308) begins to slide way from housing (3302). Similarly, to tighten(or re-tighten) the suture loop, the tensioning device (3300) may beplaced in the second configuration (as described in more detail above),and tensioning device (3300) may be pulled away from the closure device(not shown) until the tension applied to the suture reaches the secondpredetermined tension, and the first (3308) and second (3310) extensionmembers begin to pull away from the closure device. Additionally, inthese variations the tensioning device (3300) may limit the tensionapplied by the tensioning device (e.g., due to the set force applied bythe constant force springs during movement), which may help preventpremature tightening and/or over-tightening of the suture loop.

In still other instances, a tensioning mechanism (3502) described abovein relation to FIGS. 35A-35D may also be used to apply one or morepredetermined tension values to the suture loop. To release the sutureloop form the snare loop assembly, the rotation knob (3512) may berotated until rotation knob (3512) begins to rotate relative to theindicator body (3516). To tighten (or re-tighten) the suture loop, therotation knob (3512) may be further rotated until the relativepositioning between the rotation knob (3512) and the indicator body(3516) indicates that a second (or third) predetermined tension has beenreached.

It should be appreciated that some or all of the guide member orpositioning elements may be removed from the left atrial appendage atany suitable point or points during the methods. For example, in somevariations, some or all of these devices or device components may beremoved from the left atrial appendage after closing the snare loopassembly but prior to releasing the suture loop from the snare loopassembly. In other variations, some or all of these structures may beremoved after releasing the suture loop from the snare loop assembly.The suture loop may be further tightened after some or all of theseelements are removed. In still other variations, one or more expandablemembers may be detached and may remain in the left atrial appendage. Inthese variations, the expanded member may act to displace blood from theleft atrial appendage and to help keep additional blood from enteringthe left atrial appendage. When the expandable member comprises aballoon or inflatable structure, the balloon may be filled with anysuitable substance, such as, for example, saline or one or morehydrophilic polymers (e.g., hydroxyethyl methacrylate).

In yet other variations, one of the guide members or other elementsplaced inside of the left atrial appendage may be configured to releaseone or more materials to the closed left atrial appendage prior toremoval. This material may act to create haemostasis or embolization ofthe closed left atrial appendage, which may prevent the ingress andegress of blood from the closed left atrial appendage. Examples ofsuitable materials include, but are not limited to gelatins (e.g., gelfoam), liquid embolic agents (e.g. n-butyle-2-cyanoacrylate, ethidol),gelatin microspheres (e.g., polyvinyl alcohol acrylic microspheres), orpieces of thrombotic materials (e.g., platinum, stainless steel, Dacronwool, combinations thereof or the like).

In some variations, it may be desirable to lock the suture knot in placeonce the suture loop has been tightened around the left atrialappendage. In some variations, the suture knot may be locked using oneor more unidirectional locking structures, as described in more detailabove. In other variations, the knot may be locked in place with one ormore bioglues or other biocompatible adhesives (e.g., cyanoacrylate). Instill other variations, energy (e.g., RF energy, thermal energy, lightenergy, or the like) may be used to fuse the knot in place. In yet othervariations, one or more portions of the suture knot may be configured toexpand upon application of or exposure to one or more stimuli. Forexample, in some variations the suture may comprise collagen filamentsthat may be exposed to moisture when the suture is severed. Once thecollagen is exposed to moisture, it may expand to lock the suture knotin place.

Once the suture loop has been properly placed, the suture may be severedin any suitable fashion, and at any suitable location along its length(i.e., from immediately adjacent to the knot at the left atrialappendage to just proximal to, or just distal to, the skin surface). Insome instances it may be desirable to sever the suture at the knotitself (e.g., in instances where it is desirable to release tension onthe suture entirely). The suture may be severed in any suitable manner,such as for example by mechanically cutting, or by the application ofenergy. For example, the suture may be severed with the application oflight energy, thermal energy, RF energy, electrical energy, magneticenergy, electromagnetic energy, kinetic energy, chemical energy, andcombinations of any of the above.

Although the foregoing invention has, for the purposes of clarity andunderstanding been described in some detail by way of illustration andexample, it will be apparent that certain changes and modifications maybe practiced, and are intended to fall within the scope of the appendedclaims. Additionally, it should be appreciated that the closure devicesdescribed here may comprise any combination of device components andfeatures described above.

We claim:
 1. A method of closing a left atrial appendage comprising:introducing a closure device into a body, wherein the closure devicecomprises a snare loop assembly having an open configuration and aclosed configuration and comprising a suture loop releasably coupled tothe snare loop assembly; advancing the snare loop assembly to ensnarethe left atrial appendage; closing the snare loop assembly around theleft atrial appendage; applying a tension to the suture loop to releasethe suture loop from the snare loop assembly; after releasing the sutureloop, applying a first predetermined tension to the suture loop totighten the suture loop around the left atrial appendage, wherein thefirst predetermined tension is at least 10 pounds and is applied using aseparate tensioning device; and applying a second predetermined tensionto the suture loop using the separate tensioning device to re-tightenthe suture loop around the left atrial appendage.
 2. The method of claim1 further comprising opening the snare loop assembly to the openconfiguration after releasing the suture loop from the snare loopassembly.
 3. The method of claim 1 further comprising waiting a firsttime period between applying the first predetermined tension to thesuture loop and applying the second predetermined tension to the sutureloop.
 4. The method of claim 3 wherein the first time period is at leastthirty seconds.
 5. The method of claim 3 wherein the first time periodis at least two minutes.
 6. The method of claim 1 wherein the firstpredetermined tension is greater than the tension to release the sutureloop.
 7. The method of claim 1 wherein the tension to release the sutureloop is at least about 6 pounds.
 8. The method of claim 1 wherein theseparate tensioning device comprises a force gauge and a forceindicator.
 9. The method of claim 1 wherein the separate tensioningdevice comprises a rotation knob, a spooling member, a first clutch, anda second clutch.
 10. The method of claim 1 wherein the separatetensioning device comprises a housing, a first extension member, and afirst constant force spring attached to the housing and the firstextension member.
 11. The method of claim 1 further comprising couplingthe separate tensioning device to a portion of the suture loop afterapplying the tension to release the suture loop.
 12. The method of claim1 wherein the second predetermined tension is approximately equal to thefirst predetermined tension.
 13. The method of claim 1 wherein the firstpredetermined tension is greater than the second predetermined tension.14. The method of claim 1 wherein the separate tensioning deviceindicates when the first predetermined tension has been applied.
 15. Themethod of claim 1 wherein the separate tensioning device indicates whenthe second predetermined tension has been applied.